THE COMPANY
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
THE ROLE
In this multifaceted role, the Director/Senior Director, Device Engineer Combination Devices will lead the design, development, and implementation of pre-filled syringe (combination device) and will execute based on a deep understanding of injectable devices, drug product requirements, and business needs. Typical development work includes driving developing combination products for clinical and commercial applications; implementing design controls and risk management compliance; strategic engagement with external vendors and CMOs, and appropriate sequencing and interpretation of development work to ensure program goals are met. Additionally, this position will support contract manufacturing organizations to manufacture and timely delivery of drug product device assembly and packaging for clinical and commercial needs.
SPECIAL ADVISORY
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THE RESPONSIBILITIES
- Subject matter expert in engineering principles for the design and development of drug device combination products.
- Strong knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s discipline. Exposure to EU and rest of world regulatory requirements is a plus.
- Demonstrated ability to lead and integrate technologies/processes in the development, scale up and commercialization of multicomponent products that will be manufactured across a global network of CMOs.
- Experience in combination product development, design verification, human factors testing, methods development, drug device/process characterization, design controls, risk management, process development.
- Strong understanding of EU MDR 2017/745 Article 117 for a product that is a Drug per 2001/83/EC but which contain Medical Device.
- Experienced in aseptic fill finish of pre-filled syringes and device assembly for clinical and commercial supply.
- Prior implementation of DSCA compliant serialization a plus.
- Partner with QA for timely lot release, stability testing, deviation/OOS investigation, change control and data trending analysis etc.
- Write and review documents for INDs / regulatory submissions as technical SME to support regulatory interactions with the FDA and other regulatory authorities.
- In coordination with QA execute plans for overall compliance; validation and registration of Drug product as required by cGMP, ICH, FDA, and other regulations.
- Experience in tech transfer and managing CDMOs on cGMP manufacturing, deviations, change controls and OOS investigations etc is required.
- Late stage development and commercialization experience is required.
- Experience in regulatory filings (i.e. IND, CTA, BLA etc.) is preferred.
- Considerable experience working with Project/Program Management (PM) related to drug development and manufacturing.
- Demonstrated history of simultaneously managing multiple projects; success working in a dynamic, fast-paced, timeline-driven environment with short lead times.
- Superior problem-solving skills: diagnosing complex issues; developing & implementing solutions by collaborating with the appropriate internal and external stakeholders.
- A good team player with a track record of collaborations/influence up, down and across teams/organization.
- Strong communication skills (both written and oral) to summarize development work, critical conclusions and it’s relevance to the larger program. Must be able to effectively communicate and manage various CMOs and CTOs.
THE QUALIFICATIONS
- Bachelor’s Degree and 20+ years of related experience with at least 8 years of experience in medical device or combination product development or Master’s Degree and 15+ years of related experience with at least 8 years of experience in medical device or combination product development.
- PhD’s with relevant experience will be considered
SALARY
89bio considers many factors when determining level and compensation. These considerations mean actual level and compensation will vary. The salary range for this position is $225,000 - $275,000 and will be commensurate with experience.
THE PERKS
- Competitive health insurance coverage
- Generous PTO allowance
- 401k match
- Employee Stock Purchase Plan (ESPP)
- Commuter Benefits
- Women's forum / mentoring
- Office based in the heart of San Francisco, near plenty of shops and restaurants
- Fun opportunities to engage with co-workers in-person and remotely
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.
Proof of Covid vaccination is a condition of employment. Notice to Recruiters:
To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team