Principal Scientist, Product Development, Manager jobs in United States
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Catalent · 10 hours ago

Principal Scientist, Product Development, Manager

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and their San Diego facility focuses on early-stage development of small molecule and peptide drug candidates. The Principal Scientist in Product Development will lead projects in oral formulation development and be the primary point of contact for formulation strategy and compliance, while also managing a team and supporting business development activities.

BiotechnologyHealth CareManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Creates and develops innovative drug formulations and has depth of experience in one or more of the techniques described above. Performs and trains others on a variety of formulation techniques including, but not necessarily limited to: blending, encapsulation, suspensions, solutions, wet/dry/fluid bed granulation, tablet compression, coating, milling, spray drying. Perform and train others on characterization techniques (i.e. pH, osmolality, viscosity, particle size, DSC, PXRD, SEM, TGA, DVS, powder characterization, dissolution, disintegration, spectrophotometry, and chromatography
Responsible for the successful transfer of formulation projects to the GMP manufacturing team and for collaboration with process engineering team during technology transfer. Responsible for transfer of projects to late stage or commercial manufacturing sites within Catalent
Communicates results both internally and externally through oral and written updates and formal reports as necessary. Organize meetings and monitor all client interactions independently. Participate in and lead cross-functional teams. Performs secondary review of other colleagues’ work for scientific accuracy and compliance. Creates and/or revises new department-wide and site-site procedures and company SOPs
Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent’s services and will evaluate new technologies to expand our technical service offering. Individuals will proactively communicate strategy to clients and draft addendums to contracts and write and provide review of new proposals and change orders, as appropriate
Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision. Lead and train others on Continuous Improvement (CI) and innovation projects
Hire, train, and supervise formulation group members as necessary. Develop junior personnel for advancement within the team. Responsible for maintaining a GMP laboratory environment
Participate in business development and marketing activities by generating scientific expert content, hosting new client visits or teleconferences, and attending conferences or client visits to generate new leads
Other duties as assigned

Qualification

Oral formulation developmentDrug product developmentFormulation techniquesGMP manufacturingLeadership experienceClient-facing communicationContinuous ImprovementTeam management

Required

4-year degree (Bachelor's/B.S.) in a physical, chemical, biological, or pharmaceutical science required plus a minimum of eight years of drug product development experience
We will also consider candidates who have a Master of Science (M.S.) with six years' experience, or PhD with four years of experience in drug product development
Creates and develops innovative drug formulations and has depth of experience in one or more of the techniques described above
Performs and trains others on a variety of formulation techniques including, but not necessarily limited to: blending, encapsulation, suspensions, solutions, wet/dry/fluid bed granulation, tablet compression, coating, milling, spray drying
Perform and train others on characterization techniques (i.e. pH, osmolality, viscosity, particle size, DSC, PXRD, SEM, TGA, DVS, powder characterization, dissolution, disintegration, spectrophotometry, and chromatography)
Responsible for the successful transfer of formulation projects to the GMP manufacturing team and for collaboration with process engineering team during technology transfer
Responsible for transfer of projects to late stage or commercial manufacturing sites within Catalent
Communicates results both internally and externally through oral and written updates and formal reports as necessary
Organize meetings and monitor all client interactions independently
Participate in and lead cross-functional teams
Performs secondary review of other colleagues' work for scientific accuracy and compliance
Creates and/or revises new department-wide and site-site procedures and company SOPs
Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent's services and will evaluate new technologies to expand our technical service offering
Individuals will proactively communicate strategy to clients and draft addendums to contracts and write and provide review of new proposals and change orders, as appropriate
Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision
Lead and train others on Continuous Improvement (CI) and innovation projects
Hire, train, and supervise formulation group members as necessary
Develop junior personnel for advancement within the team
Responsible for maintaining a GMP laboratory environment
Participate in business development and marketing activities by generating scientific expert content, hosting new client visits or teleconferences, and attending conferences or client visits to generate new leads

Preferred

Preferred to have management experience; this person will immediately manage two people with the potential to manage a team of up to 6 in the future
Preferred to have oral formulation development experience (Tablets, capsules, granulation, spray dried dispersion/amorphous dispersions)
Strong preference for early phase development (preclinical, phase I-II with new APIs/small molecules), but will consider candidates with late stage or generics experience if they are a strong manager & communicator
Experience in a client-facing role is a plus due to regular communication with internal/external stakeholders
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Benefits

Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
Defined career path and annual performance review and feedback process.
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Several Employee Resource Groups focusing on Diversity and Inclusion.
Competitive salary with bonus potential.
Generous 401K match and Paid Time Off accrual.
Medical, dental and vision benefits effective day one of employment.
152 hours of PTO + 10 paid holidays.
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
WellHub program to promote overall physical wellness.
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

Company

Catalent

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Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)

Funding

Current Stage
Late Stage
Total Funding
unknown
2021-01-06Acquired

Leadership Team

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Alessandro Maselli
President & Chief Executive Officer
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Charles Lickfold
Senior Vice President, Chief Information Officer
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Company data provided by crunchbase