Associate Director, Lyophilized Drug Product Process & Formulations
San Francisco, United States
Job Description
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results.
THE OPPORTUNITY
Vir Biotechnology is looking for an experienced Associate Director to join Drug Product Process Development and Formulation group. The position includes developing lyophilized and liquid formulations for multiple modalities in biologics as well as supporting clinical stage process development and manufacturing. This position encompasses early and late-stage drug product development cycles. The successful candidate will conduct lyophilized formulation development for Vir molecules both internally and with contract manufacturing organizations. Responsibilities will include driving the technical aspects of formulation development, manufacturing, tech transfer, and scientific oversight of drug product and process data generated internally and with partner organizations.
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO
- Develop robust, stable and effective liquid and lyophilized formulations for monoclonal antibodies
- Support the development of manufacturing processes for parenteral dosage forms of liquid and lyophilized biologics for the clinic and market
- Perform lab work in-house as needed to support liquid and lyophilized monoclonal antibody formulation and manufacturing process development activities
- Support technical transfer of manufacturing process from development to clinical and commercial contract manufacturing organizations
- Represent the CMC organization as the subject matter expert in lyophilized pharmaceutical development
- Collaborate with clinical, drug substance process development, analytical and quality groups to maintain project timelines
- Coordinate formulation and analytical resources as needed, including those provided by production/manufacturing, quality control, quality assurance, supply, regulatory affairs
- Provide lyophilization subject matter expertise to support regulatory submissions and technical reviews
- Author technical reports, regulatory submissions, and white papers, as needed
- Work cross-functionally to support other areas of the CMC Analytical organization, such as the stability and raw materials programs
- The candidate must be able to apply advanced technical principles, theories and concepts to lyophilized drug product development
- Knowledge and familiarity with analytical methods for formulation screening of complex biological systems is preferred
- Experience with drug device combination products is a plus
WHO YOU ARE AND WHAT YOU BRING
- Bachelor’s Degree with 12+ years’ experience, master’s degree with 10+ years’ experience or PhD with 7+ years in Biosciences, Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline
- Must possess a solid understanding of pharmaceutical development, particularly as related to lyophilized biological drug development
- Must possess experience with formulation and drug product process development with lyophilized monoclonal antibodies
- Technical writing skills and experience authoring development reports, batch records, SOPs, regulatory filings, or other documents
- Ability to work in a multi-disciplinary team environment, meet deadlines, and prioritize work
- Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $177,500 to $222,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, childcare reimbursement, education reimbursement, 401K match and lunch each day in the office.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Vir Biotechnology is an equal opportunity employer. All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Apply
Career Focus: Analyst, Drug Discovery, Formulation Development
Similar Jobs
Prior Authorization Analyst Sr (Remote)
At Prime Therapeutics (Prime), we are a different kind of PBM, with a pu...
Salesforce Business Analyst
McKesson is an impact-driven, Fortune 10 company that touches virtually ...
RO Strategy & Solutions Analyst
Our team members are at the heart of everything we do. At Cencora, we ar...
Reimbursement Analyst
About Us At Gifthealth, we’re revolutionizing the way people exper...