Biotech Partners | Biotech Executive Search

Biotech Partners finds the talent that finds the cure.

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.

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.

Director of Clinical Development – Oncology Study Design

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  • Date Posted December 20, 2019
  • Location Elizabeth, New Jersey
  • Job Type Direct Hire
  • Job ID 2008

Our client is seeking a Director of Clinical Development!

This position is responsible for the strategic clinical leadership for clinical development and medical affairs activities in support of the early and late-stage development portfolio in Immuno-oncology. This role requires an individual with strong communication and leadership skills, as well as the ability to build strong relationships with key stakeholders in R&D, Medical Affairs, Business Development and other relevant functions and navigate challenging situations. The individual must also be viewed as a strong scientific partner who can readily bridge between a cutting-edge research environment and a fast-paced clinical and product development organization. The successful candidate is expected to help drive effective pre- launch clinical development and medical affairs activities and to represent the department and programs at internal and external meetings. The individual should also have experience in regulatory affairs working with CBER on immunotherapy

Specific Responsibilities:

  • Provide exceptional scientific and regulatory expertise and collaboration within the medical team, to your peers within the group, and to the organization in general.
  • Contribute to the formation, refinement and execution of medical strategies and tactics including early Phase 1b/2 and late- stage 2/3 including Investigator-Initiated Study and/or company sponsored studies and ensure medical plans optimally are integrated into Life Cycle Management (LCM) through appropriate collaborations
  • Establish and maintain relationships with key opinion leaders, investigator sites, cooperative groups, professional societies in oncology, patient groups, and external consultants.
  • Ensure medical and product information is provided in compliance with relevant SOPs and that all data used in the provision of Medical information are accurate and meet the needs of internal and external customers
  • Contribute to the development of a strategic and robust Medical Advisory Board plan that aims to enhance product knowledge and to inform on clinical practice patterns and gaps
  • Assist in the preparation publications of clinical study data and maintain a publication plan for our oncology portfolio.
  • Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
  • Excellent oral and written communications with ability to present data to all levels of audiences.
  • Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
  • Strong capability of strategic thinking and proposing innovative solutions to issues.
  • Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving.

Qualifications:

  • Minimum of 8 years of experience in clinical research working in a pharmaceutical, biotechnology or related environment.
  • Working knowledge of Clinical Drug Development
  • Working knowledge of Regulatory requirements as pertained to biologics
  • Working knowledge of Good Clinical Practice (GCP).
  • Ph.D. degree preferred (Immunology or Oncology).

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.