Biotech Partners | Biotech Executive Search

Biotech Partners finds the talent that finds the cure.

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.

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.

Medical Director (Metabolic)

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  • Date Posted April 17, 2020
  • Location Boston, Massachusetts
  • Job Type Direct Hire
  • Job ID 2084

Our client is seeking a Medical Director (Metabolic) 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 Metabolic 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's 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.

Senior Medical Director (Nephrology/Hematology)

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  • Date Posted April 13, 2020
  • Location Boston, Massachusetts
  • Job Type Direct Hire
  • Job ID 2081

Our client is seeking a Senior Medical Director 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 Senior Medical Affairs Director will provide support for strategic planning and leadership in the US for our client’s programs. Responsible for providing strong scientific and medical support with an in-depth understanding of the Nephrology/Hematology medical landscape.  Support the development and implementation of the short and long-term strategy, practices and infrastructure aligning with the overall medical affairs strategy and effective cross-functional collaboration. 

  • Lead on the situational assessment and the US product strategy development including harmonization of activities involving KOLs.
  • Develop in-year medical strategy and tactical plan for the US Medical Affairs team.
  • Implementation and budget plan for US Medical Team initiatives.
  • Provide medical strategic recommendation for in-line life cycle management (LCM) and late phase pipeline programs.
  • Support registration program working closely with GMA and geographically expansion strategy
  • Develop medically appropriate commercial strategy/tactic, planning and execution.
  • Support TA lead with team’s performance in terms of goals and delivery of US medical plans
  • Lead content development and presentation for external medical education programs and other Medical initiatives.
  • Develop, conduct, or participate in therapeutic training programs
  • Medical affairs review of field medical tools, internal commercial training material.
  • Medical affairs review of congress executive summary report.
  • Establishes strategic partnerships with centers of excellence and KOLs in areas of scientific interest and serves as conduit for flow of information both out to the medical community and into the company.

 

Qualifications:

  • Must have a MD, PhD or Pharm D level degree or equivalent
  • Experience leading Medical Affairs function
  • Proficient in Medical Governance, with extensive regulatory and compliance experience leading a Medical Affairs organization
  • Strong people management and leadership skills acquired in a multicultural environment
  • Excellent communication skills both written and verbal.
  • Ability to lead and motivate a team, both internally and remotely
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and project leader
  • Previous Clinical Operations experience (design and implementation of clinical trials)
  • Proven ability to manage budget and resources
  • Strong business acumen
  • Ability to build partnership access between HQ and affiliates
  • Flexibility and ability to adapt to changing conditions
  • Excellent problem solving, organizational, and negotiating skills
  • Must demonstrate an energy and enthusiasm which brings a positive approach to all challenges Sense of ethics and responsibility
  • Travel required up to 40%
  • Scientific and technical acumen in Nephrology or Hematology
  • Health Outcomes Research/Reimbursement 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.