Title: manager, quality control
Reports to: director, quality control
Location: redwood city, california
Classification: exempt
Overview:
Coherus biosciences is seeking a highly motivated and experienced qc professional to provide technical and operational support to coherus qcPrior experience in qc overseeing in-process, lot release and stability testing as well as expertise with the analytical and bioanalytical methods used for testing of biologics is requiredThis is an individual contributor role with potential for having a direct report depending on past experience.
This individual will work in a matrixed environment partnering with internal teams and contract organizations to ensure on time delivery of coas in support of batch release and stability testing timelines.
Knowledge and proficiency with us and multinational regulations is requiredExperience supporting commercialization and lifecycle management activities as well as experience authoring and reviewing relevant sections of the associated regulatory submissions is preferred.
Responsibilities:
Note: the following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:
Author qc protocols supporting testing activities
Manage contract laboratories
Review and trend data and support data inputs to quality program reviews (e.gPqr, qmr, ar, apqr)
Monitor lab performance via key metrics and partner with internal and external stakeholders to improve performance
Execute responsibilities in accordance with internal procedures
Lead lab investigations and capa implementation in support of qc operations
Evaluate and continuously improve qc systems and procedures to ensure compliance with current regulations
Interface with the analytical team, qa, operations and regulatory to execute coherus` operational plan
Assure qualification and validation status of lot release and stability indicating methods
Author and/or review relevant sections in regulatory submissions
Support specification development and revision as required
Support contract organization and vendor audits as required
Own pos and monitor external expenses supporting routine testing operations
Up to 20% travel as necessary to support organizational activities
Qualifications:
Bs/ba in chemistry, biology, or a related field is required; an advanced degree is preferred.
A minimum of 8 years in a gmp environment (pharmaceutical or biopharmaceutical industries) with at least 5 years in a qc laboratory overseeing qc operations
Familiarity with cgmp and multi-national regulations and guidances related to pharmaceutical and biotech products
Familiarity with statistical analyses related to pharmaceutical / biotech drug product testing and stability monitoring including familiarity with statistical software programs
Previous experience is preferred in qc lab or qc stability program in a pharmaceutical or biotech environment
A well-rounded technical background encompassing analytical methods, instrumentation, computerized systems, biology, chemistry, microbiology, statistics and/or thermodynamics is required
Familiarity with biopharmaceutical production and testing is required
Proficiency with performing root cause analysis in support of lab investigations and manufacturing deviations
Ability to solve complex technical problems
Excellent written and communication skills, scientific report writing
Strong computer skills including proficiency with statistical analysis software is desired
Beginning july 19, 2021, coherus biosciences requires all new hires to be fully vaccinated against covid-19 as of their start dateThis 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 remoteIf 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.
