Director/Senior Director, Manufacturing/Technical Operations

Director/Senior Director, Manufacturing, Technical Operations
Location:  Los Angeles/Pasadena

The Director/Sr. Director will direct all manufacturing operations for our company products at our Contract Manufacturing Organizations (CMOs). The Director will provide strong, effective technical and managerial leadership for Manufacturing, Process Development and Analytical Sciences; establish and maintain strong, collaborative working relationships between Manufacturing and other functional areas/departments and contribute significantly to the development and implementation of product development and manufacturing strategies.  Ideally, we’re looking for someone with antibody manufacturing experience.

This position will involve significant travel to contract manufacturing sites (estimated up to 25%).

RESPONSIBLITIES

* Day-to-day management/oversight of technology transfer and manufacturing activities at CMOs for company products. Serve as the primary contact for all manufacturing-related communications and interactions between CMOs and company.
* Develop and implement standard policies and procedures for evaluation and selection of CMOs. Coordinate and lead internal teams (including consultants as required) for identification, evaluation and selection of CMOs.
* Coordinate technology transfer activities between company and CMOs.
* Manage and direct the efforts of the Process Development and Analytical Sciences functions.
* Participate in manufacturing site audits
* Coordinate technical, business, and legal review and revision of development and manufacturing agreements with CMOs for company products.
* Serve as member/leader of CMC project sub teams.
* Develop, establish, and manage the clinical supply chain for company development programs, encompassing critical raw materials, production cell banks, drug substance, drug product, and packaging and labeling clinical drug product.
* Serve as company’s “Person-In-Plant” at CMO sites for critical manufacturing activities.
* In collaboration with Quality, ensure consistent product quality through development and implementation of appropriate manufacturing systems and controls.
* Develop, implement and update all manufacturing SOPs, Batch Records and other documentation needed for CGMP compliance as needed.
* Serve as primary author for manufacturing sections of regulatory submissions, and as a primary reviewer for all CMC sections of regulatory submissions.

EDUCATION

  * Ph.D. in a scientific discipline (Biology, Chemistry, Biochemistry, Microbiology, Pharmacy, Chemical Engineering, or Biochemical Engineering or M.S. with 6-8 years of relevant experience or B.S. with 8-10 years of relevant experience.

REQUIRED EXPERIENCE

* 6-8 years of biotech/pharmaceutical industry experience in process development, clinical/commercial manufacturing operations and/or contract manufacturing. Significant (4+ years) direct experience with clinical or commercial manufacturing of biopharmaceutical product(s) highly preferred.
* 2-4 years management experience at Manager level or above; significant (1-2 years) participation on cross-functional project teams as member and/or leader highly preferred.
* Proficient in use of project planning/scheduling software (e.g. MS Project)
* Antibody manufacturing experience desired.


Please send CVs to karline@crimsonsearch.com Crimson Search is an executive placement firm dedicated to the life science industry.