Biotech Partners | Biotech Executive Search

Biotech Partners finds the talent that finds the cure.

Lab Director Bioanalytical

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  • Date Posted July 13, 2020
  • Location Mattawn, Michigan
  • Job Type Direct Hire
  • Job ID 2160

Our client is seeking a Director – Bioanalytical in Kalamazoo, Michigan!

Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training and promotes a teamwork-driven environment.

Specific Responsibilities:

A Director – Bioanalytical is responsible for: managing, mentoring, and providing strategic leadership and direction to a staff of employees; preparing annual budgets and monitoring monthly forecasts, and implementation of new research activities and techniques; strengthening the core services provided to pharmaceutical, biotechnology, agrochemical and industrial clients. The individual in this position is also responsible for client relationship development; using scientific expertise to assist with business development activity; working with business development staff to develop and execute a strategic plan identifying areas or growth. In addition, the Director – Bioanalytical maintains procedures, systems and processes necessary to comply with Good Laboratory Practices. This position may be delegated the authority to perform Test Facility Management functions.

  • Ability to analyze and synthesize scientific data, interpret and prepare reports of results of chemistry projects and communicate in a timely manner with sponsor representatives, study directors, management and laboratory staff to ensure client timelines and needs are met.
  • Ability to communicate verbally and in writing at all levels inside and outside the organization.
  • Basic familiarity with Microsoft Office Suite.
  • Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
  • Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
  • Ability to work under specific time constraints.
  • Demonstrated expertise in the application of HPLC/MS/MS to the analysis of small molecules pharmaceutical agents in body fluid
  • Thorough understanding of GLP regulations and other regulatory requirements for analytical support of studies at various stages of drug development.

Qualifications:

  • PhD in Chemistry or related field with a minimum of 5 years previous
  • Experience in a management role or a master’s degree and a minimum of 10 years of experience in a management role
  • Proven leadership experience in supervising a diverse group of professional scientific employees
  • Strong coaching and staff development skills, preferably in the pharmaceutical or CRO environment
  • Superior written and verbal communication skills.

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Senior Director Oncology Biomarkers Clinical Research

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  • Date Posted July 10, 2020
  • Location Woodcliff, New Jersey
  • Job Type Direct Hire
  • Job ID 2158

Our client is seeking a Senior Director of Oncology (Biomarkers) Clinical Research position in Woodcliff, NJ!

Our client is a global pharmaceutical company that has a U.S. research-based healthcare branch. They specialize in helping patients with their products in the oncology and neurology space. The company is currently expanding, holds an excellent employee retention rate, and has a promising outlook for upward-mobility in their organization.

Specific Responsibilities:

The Senior Director of Biomarker/Translational Medicine will support the company’s oncology group through clinical research. The individual must drive development results by leading international project teams, delivering upon the agreed objectives, relating to quality, time, and cost. The Director must be a “subject matter expert” in their field, understanding how to resolve issues and developing results through project leadership. This role will lead the clinical study teams as well as the biomarker diagnostic team. The position is expected to share external-market perspectives among their team and company-wide if necessary.

  • Attend IPT team as an IPT representative or extended-members
  • Develop and review the clinical biomarker and companion diagnostic strategy and protocol.
  • Clinical biomarker/companion diagnostic management / operation
  • KOL/CRO/Vendor communication / Biomarker analysis
  • Contribution of any documents in a study team
  • Defines project vision and strategy for achieving that vision, and engages and motivates the team to buy into the vision and execute strategy through clear and persuasive communication skills
  • Leads problem-solving across the projects: facilitating team(s) to identify issues/propose solutions
  • Collaboration within the company (including cross-functional project teams) as well as with the company’s business partners – including other pharmaceutical firms, vendors (eg, companion diagnostic providers), and academic research groups
  • Ensure that the group has the information required to achieve the group’s business objectives
  • Provide technical insight as needed to ensure progress towards goals
  • Contribute innovative thinking and brings an external market perspective to the execution of the task
  • Engender trust and respect from direct reports, peers, colleagues, and senior leaders across the company by communicating openly and honestly
  • Motivate exceptional performance

Qualifications:

  • MD or Ph.D. in a related field
  • 10-15 years of Medical and/or technical development expertise within a major therapeutic area with significant industry and/or academic experience
  • Specific experience of Biomarker and Companion Diagnostic in the oncology therapeutic area
  • Significant experience of leading clinical trials and clinical study teams
  • Demonstrated ability to work with cross functional teams and working knowledge of other functional areas (e.g., clinical operations, pharmacology, pharmacokinetics, regulatory, pre-clinical and marketing)

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

CMC Operations Head

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  • Date Posted July 9, 2020
  • Location Boston, Massachusetts
  • Job Type Direct Hire
  • Job ID 2157

Our client is seeking a Head of CMC Operations in Boston, MA!

Our client is a biotechnology company which develops medicines to combat serious diseases. The company focuses on the immune, gastrointestinal, and central nervous systems as well as utilizing a cross-disciplinary approach for discovering/developing medicines with platforms in emerging disciplines.   They hold an excellent employee-retention rate and offers competitive salaries and bonus structures. And this position allows for expansion and upward mobility in the future.

Specific Responsibilities:

The Head of CMC Operations will be a key member of the management team overseeing CMC activities which will be primarily executed through external vendors. The candidate be a strong relationship manager, a strategic thinker, and have an entrepreneurial mindset.

  • Oversee API and drug product production for clinical trials including scale up and implementation of relevant analytical methods
  • Lead contract manufacturing organization selection and contract negotiations
  • Support in troubleshooting, deviation management, risk assessment and other activities related to release of cGMP material
  • Support regulatory efforts for Pre-IND and IND submissions related to CMC
  • Work closely with the company’s Project Management and Finance teams including helping to prepare budgets related to CMC activities

Qualifications:

  • An undergraduate degree in science is required; PhD is preferred
  • Minimum of 8-10 years managing CMC activities
  • Experience with small molecule and antibody therapies is required
  • Experience selecting and managing external vendors
  • Strong verbal & written communication skills
  • Experience in a small virtual company environment is helpful
  • Experience with writing the CMC portion of INDs is preferred

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Product Manager (Lumbar Fixation)

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  • Date Posted June 23, 2020
  • Job Type Direct Hire
  • Job ID 2145

Our client is seeking a Project Manager (Lumbar Fixation) near Philadelphia, PA!

Our client is a medical device company that specializes in complex spinal pathology. The company holds an excellent employee-retention rate and offers competitive salaries and bonus structures. And this position allows for expansion and upward mobility in the future.

Specific Responsibilities:

Plan and manage a large multi-functional product development project and/or several small multi-functional product development projects. The position requires strong, enthusiastic leadership skills in a highly technical medical instrument product development environment. The position requires regular interaction with scientists, hardware engineers, software engineers, technicians, marketing/sales, quality, manufacturing, vendors, administrative personnel, and senior management. Requires confidence to lead strong technical engineers and scientists in a dynamic, interactive and energetic workplace. Directs the project team in a manner to achieve the business results expected. Receives guidance on unusual and complex problems whose solution exceeds the approved project boundaries. Authority of position is that required to carry out assigned duties, except where expressly reserved by the senior management personnel or Corporate/Divisional Policy.

  • Provide technical and team leadership to one or more cross-functional project teams, including planning, scheduling, assignment of work, and technical support within the project area
  • Responsible for project planning and scheduling, clarifying and defining scope of work and project specifications, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates
  • Generates a project plan that meets business objectives and the design control process, while maximizing resource efficiency
  • Responsible for conducting regular project team status meetings and reviews
  • Ensures deliverables are completed and documented
  • Identifies the need for and implements changes to the project plan that are within approved project boundaries
  • Responsible for coordination of technical resources to identify the root cause of any project issue, and develop and manage a plan to fix, test, and implement an appropriate solution through completion
  • Responsible for ensuring project risks, both technical risks and management risks, are identified and appropriately addressed within the project plan and by project control methods
  • Develop risk mitigation plans
  • Regularly assess and report the status of overall project risk
  • Creates and maintains file to current phase ensuring accuracy
  • Responsible for project communication to both the project team and executive management
  • Able to resolve project team conflict through the application of good listening skills and negotiating skills
  • Able to remove oneself from the problem
  • Fosters creative, professional climate that will maximize the contributions of the technical staffEnsures that adequate equipment and material resources are available to advance the project and achieve goals and objectives
  • Works with other project managers to make the best use for the business of shared resources
  • Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project
  • Works with functional management to conduct performance appraisals and coaching for project core team members. Provide regular supervision for assigned Project Integrator

Qualifications:

  • BS Degree, MS/MBA preferred, in a technical or management discipline; additional course work or certification in project management is desired
  • Requires full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction
  • Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable
  • Eight years product development experience, including three years in successful technical leadership, project coordination, or project management are required
  • Having a BDM mindset is a plus
  • Sales experience is a plus

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Senior Development Engineer

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  • Date Posted June 11, 2020
  • Location Concord, Ohio
  • Job Type Direct Hire
  • Job ID 2137

Ever dream of working for CDMO industry leader, in a location with a rich culture and history, in a Research & Development position? We have the perfect position for you!

Our client is seeking a Senior Development Engineer in Cleveland, OH!

Our client is an industry-leading contract development and manufacturing organization. They specialize in chemical development using analytical chemistry, engineering/manufacturing, synthetic chemistry and specialty chemistry manufacturing. This company sets themselves apart from the competition by providing excellent customer service, delivering a consistent quality product, and first-class analytical/organic chemistry.

Specific Responsibilities:

The Senior Development Engineer will be a key contributor within a group responsible for performing purification process development, including small-scale experiments, scale-up, technology transfer and support for programs that bring new bio-pharmaceutical products to pre-clinical, clinical and commercial manufacturing phases. Serve as a compliance consultant for project teams across the company with the changing regulatory environment recommending changes to improve future development.

  • Responsible for the lab-scale development and pilot-scale demonstrations of process technology for the manufacture of new chemical-based products with emphasis on Active Pharmaceutical Ingredients
  • Works effectively in multi-disciplinary team environment
  • Applies proficiency in engineering and chemistry gained by education and experiences
  • Effectively interacts across internal divisions and with clients
  • Coordinate activities of operations and support groups (Process Chemistry, Quality Control, Analytical Chemistry, Quality Assurance, Facilities Management) to achieve project goals
  • Identifies areas of continuous improvement

 Qualifications:

  • B.S. or M.S. in Chemical Engineering with 10 or more years of experience in scale-up/preparation of pharmaceutical and specialty chemicals
  • Strong presentations and problem-solving capabilities
  • Experience in first time scale-up and preparation
  • Experience in project management
  • Demonstrate success in prior positions
  • Experience with pilot plant and kilo scale process equipment
  • Knowledgeable in process/cleaning validation and equipment commissioning/qualification
  • Good trouble shooting and problem-solving skills

 Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Senior Scientist, Downstream Process Development

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  • Date Posted June 4, 2020
  • Location Seattle, Washington
  • Job Type Direct Hire
  • Job ID 2127

Ever dream of working for an industry leader in therapeutics for oncology/hematology, in a location with a rich culture and history, in a downstream process development position? We have the perfect position for you!

Our client is seeking a Senior Scientist (Downstream Process Development) in Seattle, WA!

Our client is an industry-leading organization in the biotech space that specializes in developing therapeutics to fight cancer. They utilize cutting-edge technology, their entrepreneurial culture and the most innovative minds in the field to develop science of what’s next in biotechnology.  This platform (modular protein technology) enables next-generation sequencing. Our client sets themselves apart with proprietary technology combined with a history of innovation, dedication and development.

Specific Responsibilities:

The Senior Scientist is a hands-on position and plays an integral role in planning, design of experiments, and the daily execution of the company’s Downstream Process Development function. The primary role will be to develop and transfer robust scalable purification processes to clinical manufacturers to produce bispecific protein therapeutics for clinical trials (70% laboratory and 30% office setting). The ideal candidate would have experience with operating bench scale purification instruments, utilizing multiple chromatography modes, characterizing purification processes and filing regulatory submissions such as IND/IMPD’s

  • Work with a team to achieve product milestones
  • Operation of purification equipment (program purification methods, execute purification, and collecting/presenting purification data)
  • Detailed planning of experiments in collaboration within the process development group and other groups
  • Participation in the planning of project timelines, deliverables and milestones
  • Authoring and receiving SOP’s, batch records, production protocols, deviation assessments, technical reports for GMP’s and CMC sections for regulatory filings
  • Preparation of buffers and other purification solutions appropriate to scale
  • Occasional travel, usually domestic

Qualifications:

  • Minimum education/experience in Chemical or biochemical engineering, or related field
  • Ph.D. and two plus years in industry
  • MS/MA ten plus years of relevant industry experience
  • BS/BA and twelve plus years of relevant industry experience

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Regulatory Affairs Senior Manager

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  • Date Posted June 2, 2020
  • Location Chicago, Illinois
  • Job Type Direct Hire
  • Job ID 2124

Our client is seeking a Regulatory Affairs Senior Manager in Chicago, Illinois!

Our client is a pharmaceutical company that specializes in developing, manufacturing and marketing branded/generic drugs as well as animal/consumer health products. Additionally, they specialize in manufacturing sterile/non-sterile dosage forms. This is a well-established company in the life sciences with a lot of potential for upward mobility. This Regulatory Affairs Senior Manager position will be responsible for ensuring the completion of regulatory filings and the submission process to the appropriate authorities (FDA). This role will oversee the company’s regulatory strategy and make appropriate changes to the SOP’s when needed.

Specific Responsibilities:

  • Responsible for managing the regulatory associates/specialists and the processes in preparing and submitting documents (originals, supplements, amendments, annual reports) to the Food and Drug Administration
  • Develop the company’s regulatory strategy and implement these plans ensuring they are following FDA guidelines
  • Analyze study reports/data required during the submission process, making sure they align with FDA/ICH/CMC guidelines
  • Establish timelines/regulatory benchmarks for the company’s product development teams and key agency filing instances
  • Act as the lead for the creation of product labeling fulfilling regulatory requirements
  • Communicate with the R&D/Quality to collect appropriate data for the regulatory submissions

Qualifications:

  • Bachelor’s degree in chemistry or related field in the sciences (advanced degree preferred)
  • Ten or more years of pharma industry experience (Five plus years of direct regulatory affairs experience)
  • Motivated self-starter that understands the big picture and has a proven track record of growth/achievement with prior companies
  • A strong scientific background with extensive pharmaceutical regulatory affairs experience

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Quality Assurance Manager

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  • Date Posted May 18, 2020
  • Location Cleveland, Ohio
  • Job Type Direct Hire
  • Job ID 2113

We are working with an industry leading CRO who is looking for an experienced professional to join them in a collaborative approach on the journey of getting new drugs to market.

Our client is seeking a Quality Assurance Manager in Cleveland, Ohio!

Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training and promotes a teamwork-driven environment. This position will develop, manufacture and characterize small molecule drug substances while complying with GLP/GMP regulations. The manager will provide oversight for the company’s quality standards and systems, making improvements when appropriate.

Specific Responsibilities:

  • Review/Approve quality documentation (batch records, project protocols, validation plans, quality agreements and associated analytical data)
  • Responsible for reviewing/approving deviations, the post-investigative report and the corrective/preventative actions to implement going forward
  • Conduct regular audits to ensure all compliance and standards are met
  • Responsible for enforcing Good Manufacturing Practices (GMP) and supplier/material qualification
  • Manage study data related to the company’s quality standards
  • Monitor change control, deviations, and CAPAs through the QMS database
  • Responsible for three to five direct reports
  • Responsible for archives, document control and implementing a training program
  • Manage inspections by regulatory governing bodies (FDA/EMA)

Qualifications:

  • BS in a technical field or a minimum of 7-10 years of experience of in the pharmaceutical/ biotech industry
  • Five or more years in QA manufacturing and small molecule characterization
  • Knowledge of drug development process
  • Familiarity with data integrity and qualifying equipment
  • Experience managing multiple priorities and quality assurance staff

Qualified Candidates, Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Senior Process Chemist (2)

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  • Date Posted May 18, 2020
  • Location Cleveland, Ohio
  • Job Type Direct Hire
  • Job ID 2111

We are working with an industry-leading CRO who is looking for an experienced professional to join them in a collaborative approach on the journey of getting new drugs to market.

Our client is seeking a Senior Process Chemist in Cleveland, Ohio!

Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training and promotes a teamwork-driven environment.

Specific Responsibilities:

  • Hands-on laboratory chemical development of robust, safe and scale-able processes for operation and plant equipment
  • Lead one or more synthesis projects and provide support to other projects as required
  • Provide strong and consistent support for pilot plant projects
  • Assist in analysis of client RFPs and provide technical input to generation of proposals
  • As project leader, serve as primary contact with the client, write project updates and chair teleconferences
  • Routinely assumes the primary investigator /project leader role
  • Analyzes synthetic routes and processes provided by clients, obtains accurate process data, solves challenging synthetic chemistry and processing problems as required to meet client goals
  • Has a working knowledge of cGMP regulations, process scale-up requirements, and process chemistry techniques
  • Has a working knowledge of Kilolab and pilot plant operations
  • Maintains strong working relationship with other departments (Analytical, PD&E, Regulatory Affairs, Client Services) and develops an understanding of the work done by these departments
  • Supervises and mentors scientific staff.
  • Proficient in standard analytical techniques (TLC, NMR, HPLC, LC/MS, GC, etc.)

Qualifications:

  • PhD level in Organic Chemistry
  • 5+ years of experience in pharmaceutical process development for scale up of intermediates and API into Kilolab and pilot plant facilities
  • Experience in a CRO or CMO environment is desirable

Qualified Candidates, Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Medical Director (Neurology)

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  • Date Posted April 17, 2020
  • Location Boston, Massachusetts
  • Job Type Direct Hire
  • Job ID 2088

Our client is seeking a Medical Director of Neurology in Boston, MA!

Our client specializes in treating rare disorders/autoimmune diseases in the pharmaceutical industry. The company holds an excellent employee-retention rate and offers competitive salaries and bonus structures. And this position allows for expansion and upward mobility in the future.

Specific Responsibilities:

The Medical Director will advance the understanding of the medical landscape in relation to the rare disorder and treatment and support the development and implementation of appropriate strategies within the country aligned with the Global Medical Affairs strategy for the overall Neurology franchise. These activities include, but are not limited to, medical strategy and launch planning, life cycle management data generation, publications, scientific exchange, advisory boards, medical insights, and thought leader development. Lead on the situational assessment and the US product strategy development including harmonization of activities involving KOLs.

  • Define medical resource needs, and manage budget planning and resource allocation
  • Conduct advisory boards, develop and maintain relationships with top thought leaders, and utilize medical insights from the field teams to inform the Medical Product Plan.
  • Deliver and execute local Medical Product Plan aligned with Global Medical Product Plan.
  • Ensure timely country publication planning and communication activities in supportive of Global Medical Affairs strategy.
  • Identify and implement appropriate high-impact medical research projects to support the strategic objectives, including company–sponsored and investigator-initiated projects
  • Collaborate with global medical education team to localize (and develop as needed) medical content for scientific exchange by field medical team
  • Provide appropriate and timely medical affairs support to key commercial and reimbursement activities aligned with strategic priorities.
  • Review and approve promotional materials to ensure information is accurate, relevant to the Country environment, and ensure medical accuracy.
  • Support medical information function, ensure timely response to medical information inquiries and collation of requests, utilizing global medical information resources and in line with local regulatory requirements and company policy.
  • Ensure effective team communication, performance and documentation of medical affairs activities and knowledge through the application of suitable reporting systems and structures
  • Identifying training needs in collaboration with key stakeholders and ensure implementation of medical training programs for the field medical team as well as other cross-functional members as appropriate.
  • Collaborate with Clinical Operations to manage the in country Clinical Operations Lead role and ensuring their activities are prioritized to meet the clinical operations and country objectives.

Qualifications:

  • Medical degree (M.D.), Pharm D or Ph D
  • Minimum of 5+ years in medical affairs
  • Product lifecycle management experience preferred
  • Orphan diseases knowledge/experience preferred but not required
  • Demonstrated ability to create and lead successful cross-functional teams in changing, competitive environments
  • Demonstrated ability to influence important customers, challenge common perceptions and implement medical affairs tools to improve patient care and outcomes
  • Good analytical skills as applied to medical, scientific and technical information.
  • Demonstrated ability to accurately and effectively evaluate medical/scientific literature and develop effective medical strategies and communication strategies.
  • Demonstrated experience in early and late clinical development.
  • Excellent written and verbal communication skills in both local language and in English
  • Adaptability to multicultural environment

Qualified Candidates Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.