Associate Director, Drug Product Manufacturing
Coherus BioSciences, Inc., Redwood City, CA, United States
Associate Director, Drug Product Manufacturing
Redwood City, CA
Title:
Associate Director, Drug Product Manufacturing
Reports to:
Vice President, Manufacturing
Location:
Redwood City, CA
Classification:
Exempt
Overview:
This position will provide technical leadership for drug product technology transfers and manufacturing, including CMO oversight to ensure successful clinical and commercial cGMP production. Scope entails development and implementation of fill/finish processes for novel immuno-oncology products.
Responsibilities:
Drug Product Process Development
Lead technology transfers for drug product manufacturing
Oversee efforts at CMOs to ensure vial aseptic fill technology transfer activities are executed per process development procedures and best practices
Provide technical leadership to identify, design, execute, evaluate, and document studies characterizing drug product processes based on solid scientific and engineering principles
Author CMC sections of regulatory submissions
Act as technical point of contact during regulatory agency interactions
Mentor/coach junior staff and support their professional development
Formulation and Fill/Finish Manufacturing
Serve as technical site lead for CMOs and provide subject matter expertise for drug product manufacturing unit operations
Partner with CMOs to ensure successful clinical and commercial cGMP production
Provide technical support to manage deviations, corrective actions, change controls, process monitoring, and process improvements
Represent Coherus as person-in-plant during production runs
Quality and Compliance
Ensure corporate standards are met in both quality and compliance with cGMP standards
Ensure compliance with international (ICH, EMA), and S. (CFR, FDA, OSHA) regulations and ensure adherence to all company policies and procedures relating to Good Manufacturing Practices, EH&S practices, etc.
Author, review, and approve SOPs required for drug product process development activities
Qualifications:
Minimum BS required, degree in chemical engineering or similar field
Minimum of 10 years’ drug product experience in the biopharmaceutical industry
Must have strong knowledge of biologics manufacturing and aseptic processing expertise
Demonstrated track record of successful drug product process development
Must have knowledge of applicable Quality and Regulatory guidelines
Prior experience managing third party CMO relationships and as person-in-plant during manufacturing runs
Must have strong interpersonal skills and the ability to communicate effectively with external partners, peers, and senior management
Must work well in cross-functional teams and effectively mentor junior team members
Ability to travel domestically and internationally, up to 25%
Must have strong computer skills, including MS Office applications
Experience with statistical methodologies and software such as JMP or Minitab desirable
The Base Salary Range for this position is $170,000 to $200,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has or is perceived as having any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.
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Title:
Associate Director, Drug Product Manufacturing
Reports to:
Vice President, Manufacturing
Location:
Redwood City, CA
Classification:
Exempt
Overview:
This position will provide technical leadership for drug product technology transfers and manufacturing, including CMO oversight to ensure successful clinical and commercial cGMP production. Scope entails development and implementation of fill/finish processes for novel immuno-oncology products.
Responsibilities:
Drug Product Process Development
Lead technology transfers for drug product manufacturing
Oversee efforts at CMOs to ensure vial aseptic fill technology transfer activities are executed per process development procedures and best practices
Provide technical leadership to identify, design, execute, evaluate, and document studies characterizing drug product processes based on solid scientific and engineering principles
Author CMC sections of regulatory submissions
Act as technical point of contact during regulatory agency interactions
Mentor/coach junior staff and support their professional development
Formulation and Fill/Finish Manufacturing
Serve as technical site lead for CMOs and provide subject matter expertise for drug product manufacturing unit operations
Partner with CMOs to ensure successful clinical and commercial cGMP production
Provide technical support to manage deviations, corrective actions, change controls, process monitoring, and process improvements
Represent Coherus as person-in-plant during production runs
Quality and Compliance
Ensure corporate standards are met in both quality and compliance with cGMP standards
Ensure compliance with international (ICH, EMA), and S. (CFR, FDA, OSHA) regulations and ensure adherence to all company policies and procedures relating to Good Manufacturing Practices, EH&S practices, etc.
Author, review, and approve SOPs required for drug product process development activities
Qualifications:
Minimum BS required, degree in chemical engineering or similar field
Minimum of 10 years’ drug product experience in the biopharmaceutical industry
Must have strong knowledge of biologics manufacturing and aseptic processing expertise
Demonstrated track record of successful drug product process development
Must have knowledge of applicable Quality and Regulatory guidelines
Prior experience managing third party CMO relationships and as person-in-plant during manufacturing runs
Must have strong interpersonal skills and the ability to communicate effectively with external partners, peers, and senior management
Must work well in cross-functional teams and effectively mentor junior team members
Ability to travel domestically and internationally, up to 25%
Must have strong computer skills, including MS Office applications
Experience with statistical methodologies and software such as JMP or Minitab desirable
The Base Salary Range for this position is $170,000 to $200,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has or is perceived as having any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.
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