Associate Director, Biologics Development (Remote / Home Based)
Company: Jazz Pharmaceutical
Location: San Francisco
Posted on: April 24, 2024
Job Description:
If you are a Jazz employee please apply via the Internal Career
siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
- often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines and novel product candidates, from
early- to late-stage development, in neuroscience and oncology. We
actively explore new options for patients including novel
compounds, small molecules and biologics, and through cannabinoid
science and innovative delivery technologies. Jazz is headquartered
in Dublin, Ireland and has employees around the globe, serving
patients in nearly 75 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.Brief
Description:Jazz Pharmaceuticals is seeking an Associate Director,
Biologics Drug Product (DP) Development to join our Biologics
Development team. S/he will support the development of recombinant
therapeutic proteins including antibodies, bispecifics and ADCs
from clinical to late-stage development by serving as a Subject
Matter Expert (SME) in formulation and drug product development.
The successful candidate will have deep understanding of liquid and
lyophilized formulation development for biologics, protein
degradation pathways, biophysical characterization studies, drug
product process development, tech transfer, process
characterization, risk assessment and implementation of control
strategies. Management of CROs and CMOs will be a critical aspect
of the position as most of the development and manufacturing
activities are outsourced. The position requires excellent oral and
technical writing skills to author and review regulatory filings.
This position reports to the Senior Director of Biologics
DevelopmentEssential Functions/Responsibilities
- Provide subject matter expertise (SME) in Biologics Formulation
and DP process development including lyophilized presentation
development.
- Author and review CMC modules of IND and BLA filings
- Support tech transfer of biologics drug product processes to
commercial scale contract manufacturing organizations (CMOs)
- Serve as Person in Plant (PiP) during batch production to act
as liaison between manufacturing facility and Biologics drug
product team
- Design and implement strategies for drug product process
improvements and characterization at CMOs
- Collaboration with cross-functional teams to drive and deliver
on multiple projects
- Domestic and International travel for up to 10-15 days per year
supporting manufacturing campaigns, project meetings and
development operations
- Keeps abreast of industry best practices and technological
advancements in biologics manufacturing and utilizes those to
further enhance department's capabilities.
- Completes all EHS related training and ensures Jazz development
and commercial production operate safely and adhere to all
regulatory requirements Required Knowledge, Skills, and
Abilities
- Strong knowledge of protein and peptide formulation development
techniques, stability assessment, forced degradation studies,
biophysical characterization techniques.
- In-depth understanding and hands-on experience in development
of Biologics DP processes, formulation development including lyo,
liquid and high concentration biologics
- Experience in setting up DOE and in-use studies to support
clinical administration
- Skilled at technical writing and prior experience authoring and
reviewing IND and BLA filings
- Demonstrated experience in tech transfer of a process from
development to manufacturing or between manufacturing sites.
- Understanding of Phase appropriate regulatory requirements for
Biologics Drug Product processes
- Able to solve complex and diverse scientific and technical
problems through original thinking and deductive reasoning.
- Proficiency in manipulation, analysis and trending of data in
Excel and statistical programs.
- Excellent verbal and written communication skills
Required/Preferred Education and Licenses
- > 10 years of hands-on development experience. Degree in
Pharmaceutical Sciences, Biotechnology, Chemical Engineering,
Biochemistry or equivalent with at least a Master's degree
preferred Jazz Pharmaceuticals is an equal opportunity/affirmative
action employer and all qualified applicants will receive
consideration for employment \r\nwithout regard to race, color,
religion, sex, national origin, disability status, protected
veteran status, or any characteristic protected by law.\r\nFOR
US-BASED CANDIDATES ONLYJazz Pharmaceuticals, Inc. is committed to
fair and equitable compensation practices and we strive to provide
employees with total compensation packages that are market
competitive. \r\nFor this role, the full and complete base pay
range is $156,000-$234,000. Individual compensation paid within
this range will depend on many factors, including qualifications,
skills, relevant experience, job knowledge, and other pertinent
factors. The goal is to ensure fair and competitive compensation
aligned with the candidate's expertise and contributions, within
the established pay framework and our Total Compensation
philosophy. Internal equity considerations will also influence
individual base pay decisions. This range will be reviewed on a
regular basis. \r\nAt Jazz, your base pay is only one part of your
total compensation package. The successful candidate may also be
eligible for a discretionary annual cash bonus or incentive
compensation (depending on the role), in accordance with the terms
of the Company's Global Cash Bonus Plan or Incentive Compensation
Plan, as well as discretionary equity grants in accordance with
Jazz's Long Term Equity Incentive Plan. \r\nThe successful
candidate will also be eligible to participate in various benefits
offerings, including, but not limited to, medical, dental and
vision insurance, 401k retirement savings plan, and flexible paid
vacation. For more information on our Benefits offerings please
click here: https://careers.jazzpharma.com/benefits
Keywords: Jazz Pharmaceutical, Daly City , Associate Director, Biologics Development (Remote / Home Based), Executive , San Francisco, California
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