Director, CMC

Location
Progenity, Inc. Headquarters
Posted
Sep 03, 2020
Ref
R947
Required Education
Doctorate/PHD/MD
Position Type
Full time

Our mission at Progenity is simple: to help healthcare providers and patients prepare for life. We provide the most advanced molecular technology and the highest levels of service to guide patient care at critical life stages. We continually seek people with the motivation and skills to advance our mission.

The Director of CMC will work in a cross functional to support the various therapeutic programs for Progenity’s Precision medicine division.

RESPONSIBILITIES

  • Carries out the formulation and process development of the company’s proprietary drug delivery products.
  • Participates in process scale-up and manufacturing activities to provide quality materials for nonclinical and clinical trials.
  • Evaluates and manages tech transfer with contract manufacturing organizations.
  • Manages a global network of CMOs and CROs for development work related to small and large molecules.
  • Maintains accurate lab notebooks and complete development reports.
  • Authors and reviews relevant documents required to support IND and BLA regulatory submissions.
  • Authors and reviews production batch records for the manufacturing of GMP materials.
  • Cooperatively works with personnel in other departments and collaborators: Analytical Development, Quality Assurance and Regulatory Affairs, and collaborating partners.
  • Identifies and evaluates new technologies for the company’s portfolio.
  • Travels to various partner sites as needed.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.

REQUIREMENTS

  • PhD in pharmaceutics, industry pharmacy, biochemistry, chemical engineering, biomedical engineering or any equivalent major.
  • Over 10 years of working experience in biotech or pharmaceutical companies with prior experience in small molecule and biologics formulation and process development.
  • Experience managing a global network of CMOs and CROs for various development activities.
  • Prior experience with medical devices or combination products highly desirable.
  • Good knowledge and understanding of cGMP regulations and ICH guidelines.
  • Excellent verbal and written communication skills; capable for writing reports and analytical methods.
  • Team player with ability to positively communicate with team members.
  • Must be highly organized and able to work independently in a fast-paced environment.
  • Must be professional, dedicated, detail-oriented, and self-motivated.
  • Proficiency with word-processing, spreadsheet, chemical drawing, and basic statistical analysis (i.e. MS Word, Excel, ChemDraw, JMP etc.)