Sr Container Closure Engineer II/Senior Manager, MS&T
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
This position is responsible for providing technical expertise and leadership in the selection, qualification and implementation of components and container closure systems for drug substance and drug product to support clinical and commercial projects. The Container Closure Engineer (CCE) represents the MS&T and leads the execution and documentation of primary packaging deliverables within a cross-functional CMC team environment. The Sr. Engineer will engage and work with both internal (product/process development teams) and external partners (CMOs) in characterization and documentation reviews to ensure all of the components and container closure systems drawings and specifications, assembly drawings, tolerance stack analyses, risk analyses, etc. meet company’s incoming specifications/standards before introducing into clinical or commercial manufacturing facilities. The incumbent is expected to work closely with regulatory in preparation/coauthoring regulatory filings (CTAs, BLAs, CBE and PAS) and addressing issues associated with CMC actionable complaints relating to components and container closure systems for drug substance and drug product. The individual will also serve as a key components and container closure systems owner in leading CMOs on establishing GMP processes, driving qualification of new vendors/sites for second sourcing and providing technical leadership during quality investigations of complex deviations/non-conformances.
This position requires an individual with proven track record of achievement in managing complex manufacturing execution systems, excellent/effective communication and people skills.
Job Responsibilities:
- Represent Manufacturing Sciences and Technology (MS&T) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities relating to components and container closure systems for drug substance and drug product for clinical and commercial tech transfer, validation, supply/supply chain, quality/ compliance, change management and product life cycle management.
- Participate in cross functional business and scientific initiatives as the MS&T representative, and effectively collaborate and influence cross-functional partners to support MS&T objectives.
- Lead selection, qualification and implementation of components and container closure systems for drug substance and drug product (glass vials, elastomeric stoppers, cartridges, pre-filled syringes and IV bags).
- Work closely with internal and external partners (CMOs) to conduct risk assessments to evaluate components, systems, suppliers, processes and in maintaining material inventory.
- Design and execute activities in support of components and container closure systems design, selection, characterization testing, and system qualification for dosage form-specific projects in alignment with quality system procedures and business practices. Provide technical review for components and container closure systems specifications and incoming release testing protocols.
- Partner with extractables / leachables and toxicology colleagues in performing safety assessments of material of construction of components and container closure systems.
- Participate as needed in the review and approve of the technical documentation including protocols, master batch records, and reports related to engineering run, GMP run and PPQ runs.
- Partnering with product development, manufacturing, quality and regulatory, lead quality investigations and data analysis as CCE SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place.
- Develop and implement control strategy, identify and implement operational improvements and identify novel technological approaches to improve product quality attributes and enhance yield.
Knowledge, Experience and Skills:
- Degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field preferred.
- PhD with 0 years of relevant work experience; or Masters degree with 6 + years of relevant work experience; or Bachelors degree with 10+ years of relevant work experience.
- Experience with parenteral pharmaceutical container closure systems and understanding of current US and global Regulations, US/EU/JP Compendia, ISO standards, quality system regulations (Part 4) for combination products, Container Closure Systems for Packaging Human Drugs and Biologics FDA guidance document, and other applicable FDA and ICH guidance is highly desirable.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- Excellent and effective verbal and written communication skills.