Associate Director, Pre-Commercial, Quality Control

Title:                                     Associate Director, Pre-Commercial, Quality Control
Reports To:                          Vice President, Quality Control
Location:                              Redwood City, California
Classification:                     Exempt

Overview:   

Coherus BioSciences is seeking a highly motivated and experienced QC professional to provide technical leadership to Coherus’ clinical programs with direct responsibility for the QC strategies and deliverables supporting product developmental activities. This position reports directly to the head of Quality Control at Coherus.

The position defines and executes the analytical strategies for implementation of an integrated control system and oversees method validation, QC site selection and transfer, and monitors method performance and ongoing project deliverables. 

The position also oversees establishment of reference standards, completion of release and stability testing for assigned programs, participates in product quality data reviews and provides technical input and leadership to laboratory and manufacturing investigations.  The position requires a broad knowledge of quality and QC as well as proficiency with 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 review 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, 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:

• Oversees QC method life cycle from early development through commercialization
• Coordinates and leads activities performed at contract testing laboratories (CTLs) associated with method development/optimization, validation and transfer.
• Provides technical review of test records and raw data related to release testing of drug substance, drug product, final finished product and reference standards.
• Provides technical review of stability data
• Establishes product-specific QC release and stability test methods, method controls.
• Provides QC technical review and input for product characterization and manufacturing process changes and leads analytical comparability design and execution for post approval changes
• Serves as the QC technical lead in developing specifications for drug substance, drug product and combination product.
• Collaborates with regulatory-CMC in defining technical content for submissions as well as author and review analytical sections for regulatory submissions.
• Supports regulatory inspections and internal audits as required
• Participates in the selection and auditing of contract organizations
• Supports QC routine operations to establish and implements processes to enable effective collaboration with business partners to ensure efficient and high quality results.
• Identifies and establishes relationships with external consultants/subject matter experts to leverage knowledge and experience not available internally.
• 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 10 years direct experience in QC or analytical development for biopharmaceutical products with exposure to all stages product development
• Prior experience in working in a matrixed environment is preferred
• Demonstrated track record of leading and managing development of analytical methods, CRO management, and qualification and transfer activities.
• Experience and proficiency with analytical comparability supporting post approval changes is preferred
• Experience with device development is preferred
• Strong knowledge of CMC analytical and regulatory requirements, including establishment of product specifications governing biologics product development.
• Hands-on working experience in IND, NDA/BLA authoring, submission and approval.
• Ability to solve complex technical problems
• Familiarity with statistical analyses related to pharmaceutical / biotech drug product stability, including statistical software programs
• Proficiency with cGMPs and multi-national regulations related to pharmaceutical and biotech products
• Excellent written and communication skills, scientific report writing
• Strong computer skills
• Ability to travel domestically and internationally up to 15%

Language Skills

Ability to write reports, presentations, and business correspondence.  Must effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Physical Requirements

While performing the duties of this job, the employee may be required to perform lifting tasks of up to 10 pounds for short durations.  Duties of this job may involve standing and/or walking for extended periods of time.  Duties also involve daily keyboard data entry.  Specific vision abilities required by this job include close vision and color vision.

Work Environment

The noise level in the work environment is usually moderate. 

Safety

Coherus is committed to the health and safety of our employees.   We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.