Associate Director, Biologics Formulation and Fill Finish Process Development
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Associate Director (AD) of Formulation & Fill Finish Process Development will provide scientific evaluation and direction for the development and validation of patient convenient formulations and robust aseptic fill finish processes for liquid and lyophilized biologics. This position requires solid understanding of aseptic processing principles as applied to parenteral sterile liquid and lyophilized drug product manufacturing, hands-on experience with the use of multivariate process analytics and statistical or other experimental design techniques (MVA, DOE, QbD) to drive complex, technical workflows to ensure successful process unit operations integration with the product formulation and delivery device requirements. In depth knowledge of scale down models and design of edge of failure experiments simulating compounding, mixing, sterile filtration and filling operations for both liquid and lyophilized dosage forms is required. Experience manufacturing high concentration, viscous biologics is a plus. Additional requirements include solid experience characterizing process and container closure parameters ranges, critical for fill finish operations of combination products, demonstrated record successfully developing and outsourcing fill finish processes from early stage to commercialization including life cycle management, experience in supporting validation campaigns, etc. This position has accountability for technical decision-making and will be a major contributor to the writing of technical development reports as well as global regulatory submissions. The AD will be responsible for Drug Products manufacturing for clinical campaigns according CMC project development plan, timeline and resources. The Associate Director will work with the Clinical, Quality, Regulatory, and Supply Chain organizations to ensure that our products meet the highest quality and supply standards. This position reports to the Senior Director of Biologics Drug Product & Device Development.
- Provide technical leadership of formulation and drug product process development and validation for liquid and lyophilized biologics. Oversee external CMO, work flow, progress, and milestone achievements.
- Responsible for formulation and fill finish process development and validation, knowledge management according QMS requirements, regulatory filings and drug products launch support for biologics.
- Conduct risk assessment for drug product operations to support fill finish process development, scale up, technical transfer, and clinical manufacture.
- Spearhead operational excellence and process improvement initiatives to improve product quality, reliability and reduce risk.
- Lead process modeling, data trending and advanced statistical & process analysis.
- Design and manage appropriate development, stability and stressed studies, and organize analysis and reporting of data
- Comply with applicable GMP, regulatory, ISO and other professional requirements for parenteral drug products during development, validation and commercialization.
- Responsible for CMC support of regulatory filings for formulation and aseptic fill finish process.
Required Knowledge, Skills, and Abilities
- Experience in directing formulation and drug product process development from preclinical to post-approval.
- Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills with ability to multi-task
- Proficiency managing contract product manufacturing for biologics as well as drug product fill finish process scale up and technology transfer.
- Demonstrated proficiency in troubleshooting and problem solving and use of experimental design to elucidate effects of variables. Experience with computational fluid dynamics is desirable.
- Excellent written and verbal communication skills .
- Ability to collaborate with Global Manufacturing, Supply, Quality, Regulatory and other functions to ensure manufacturing processes are commercially viable and meet highest quality and supply standards.
- Design and manage appropriate stress and stability studies. Organize analysis and reporting of data
- Provide support to project teams and participate in strategies for product development and obtaining regulatory approval.
- This position requires proven abilities and skills in leadership, project management and working in cross-functional work teams.
Required/Preferred Education and Licenses
- Master’s or Ph.D. degree in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field is required.
- At least 7 years of hands-on experience in aseptic drug product fill finish and formulation development and validation for biologics preferably in pharmaceutical or biotech company. Experience in outsourcing and project management is strongly preferred.
- The ideal candidate will have previous formulation and fill finish process project managementexperience from early feasibility to commercialization. Deep understanding of global regulatory guidance documents for parenteral sterile liquid and lyophilized drug product manufacturing is required.
- Strong technical writing and oral communication skills are required. Experience preparing information for IND, BLA, PMA, etc. submissions is a plus.
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
- Requirements associated with international and domestic business travel.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Periodic business meetings and trade shows requiring appropriate business apparel.