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Biotech Partners | Biotech Executive Search

Biotech Partners | Biotech Executive Search

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Lab Director Bioanalytical

July 13, 2020 by

  • 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.

CMC Operations Head

July 9, 2020 by

  • 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.

Director of Clinical Development – Oncology Study Design

December 20, 2019 by

  • 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.

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Biotech Partners finds the talent that finds the cure. From helping you find the perfect life sciences candidate or matching applicants up with their dream role, you’ll find Biotech Partners committed to your success. That’s why we have a 5-year quality guarantee.

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