Manager/Senior Manager Pre-Commercial, Quality Control

Title:                                  Manager/Senior Manager Pre-Commercial, Quality Control
Reports To:                      Executive Director, Pre-Commercial Quality Control
Location:                          Redwood City, California
Classification:                  Exempt

Overview:   

Coherus BioSciences is seeking a highly motivated QC professional to provide technical leadership to Coherus’ clinical programs with direct responsibility for deliverables supporting product developmental activities. This position reports directly to the Executive Director, Pre-Commercial Quality Control.

The position implements the analytical strategies of an integrated control system for pre-commercial (clinical) programs. The position will oversee the testing and release of drug substance and drug product at contract manufacturers and service providers.  The role is responsible for method validation/optimization/transfer, and monitors method performance at contract service providers.

The position also is responsible for qualification and management of reference standards, and establishment of specifications for assigned programs, participates in product quality data reviews and provides technical input and leadership to laboratory and manufacturing investigations (i.e. OOS/OOT). The position requires knowledge of Quality and QC, as well as strong knowledge of the analytical and bioanalytical methodologies used in control systems for in-process, release and stability monitoring of biological products. Proficiency with cGMPs and application of multi-national regulations is required. 

Additionally, this position is responsible to author and/or review analytical relevant CMC sections and contribute to HA communications, briefing documents for scientific advisory meetings as well as responses to health authority information requests. 

Success is achieved through collaboration with internal and external partners in regulatory, analytical development, quality assurance and process development and operations and requires prior experience working in highly matrixed environments and with contract organizations.

Principal Responsibilities and Duties:

Note:  The following is meant to be representative but not inclusive of the duties and responsibilities for this position:

• Manages QC method life cycle from early development through commercialization.
• Coordinates and oversees activities performed at contract testing laboratories (CTLs) associated with method development/optimization, validation, and transfer.
• Establishes product-specific QC release/stability test methods, and method controls.
• Provides technical review of test records and raw data related to release testing of drug substance, drug product, and final finished product,.
• Manages pre-commercial stability studies and provides technical review of stability data.  Collaborates with QC Stability group to provide data for trending. Ensures pre-commercial stability studies at CTLs are on-track and issues such as OOS/OOTs are detected and addressed promptly.
• Establishes product-specific QC release and stability test methods, method controls.

• Provides QC technical review and input for product characterization and manufacturing process changes.
• Manage reference standards program, coordinate sourcing, ensure inventory, plan and execute testing and retesting activities, and manage shipments of reference standards.

• Provides QC support for developing and setting specifications for drug substance, drug product and combination product.
• Collaborates with regulatory CMC by providing technical support, drafting and/or reviewing analytical sections for regulatory submissions.
• Supports regulatory inspections and internal audits as required.

• Author, review and approve various analytical/QC reports in a timely manner to support drug substance and drug product development and manufacture, and regulatory filings.

• Supports QC routine operations to establish and implement processes to enable effective collaboration with business partners to ensure efficient and high-quality results.
• Proficient with GMPs and application of compendial requirements and multinational regulations.

Experience, Education, Training, Traits:

• BS in Chemistry, Biology, Biochemistry or related technical discipline; PhD or MS is preferred.
• Minimum of 5 years direct experience in Quality Control for biopharmaceutical products with exposure to all stages of product development.
• Prior experience in working in a matrixed environment is preferred.
• Demonstrated track record of leading and managing deve