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Company

Original Job Post

Boehringer Ingelheim · 3 days ago

Director, Late-Stage Drug Product Development

North Brunswick, NJ

Full-time

Hybrid

Director

10+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Provide leadership, training, and supervision of the local Late-Stage Drug Product Development team.

Complete and maintain Environmental, Health and Safety (EHS) and Good Manufacturing Practice (GMP) related trainings.

Ensure all Late-Stage Drug Product Development Science activities meet project timelines.

Support Chemistry Manufacturing Control-Technical Development Team for project success.

Author and review process development reports and pharmaceutical submission documentation.

Execute overall GMP campaign operation including secondary packaging, batch manufacturing, and process development trials.

Evaluate and implement new technologies for Drug Product manufacturing and control.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Drug Product Process DevelopmentPeople ManagementRegulatory SubmissionsStatistical Tools MinitabStatistical Tools JumpSolid Oral Dosage FormsPharmaceutical Internal GovernanceBudget ManagementResource AllocationDrug Product Development Transfer

Required

Doctorate degree (US or foreign equivalent) in Pharmaceutics, Chemistry, Chemical Engineering, or a related field

Ten (10) years of experience in the job offered or in a related role OR Master's degree (US or foreign equivalent) in Pharmaceutics, Chemistry, Chemical Engineering, or a related field and twelve (12) years of experience in the job offered or in a related role

Eight (8) years of experience with drug product process development

Five (5) years of experience with: people management including direct supervision; utilizing understanding of U.S. pharmaceutical regulatory expectations (such as FDA) in the development of finished drug product processes and regulatory submissions; leading the interactions with pharmaceutical R&D and Manufacturing functions; developing solid oral dosage forms pharmaceuticals; using statistical tools such as Minitab or Jump; and, working with external pharmaceutical service provider such as CRO or CDMO

Three (3) years of experience participating in pharmaceutical internal governance structure

Two (2) years of experience directly managing budgets and allocating resources

Experience completing one (1) full drug product development transfer into manufacturing

20% domestic and international travel required

Company

Boehringer Ingelheim

Glassdoor

4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10,001+ employees

https://www.boehringer-ingelheim.com/

H1B Sponsorship

Boehringer Ingelheim 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

Trends of Total Sponsorships

2023 (8)

2022 (10)

2021 (16)

2020 (2)