M.C. Dean, Inc

Jazz Pharmaceuticals is seeking an Associate Director, Biologics Drug Product (DP) Development to join our Biologics Development team.. 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.. Support tech transfer of biologics drug product processes to commercial scale contract manufacturing organizations (CMOs). Strong knowledge of protein and peptide formulation development techniques, stability assessment, forced degradation studies, biophysical characterization techniques.. 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.

associate director

If you are a Jazz employee please apply via the Internal Career site Jazz 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 Development Essential 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 without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US-BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $156,000-$204,750. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience. At 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. The 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
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