Senior Manager, Pharmaceutical Development

Ferring Pharmaceuticals A/S

Fuldtidsjob
Udlandet (øvrige)

Senior Manager, Pharmaceutical Development


Job Title:

Senior Manager, Pharmaceutical DevelopmentJob Description:

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology), orthopedics and Oncology. Ferring’s US operations employ approximately 900 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:

See responsibilities and requirements below.

Responsibilities:

  • Experience in pharmaceutical development, including a broad knowledge of drug development. Responsible for drug product technical development through regulatory approval, including process optimization, technology transfer, pilot scale development, scale-up to commercial scale, and process validation.
  • Project management in planning and executing multiple projects from definition through completion. Lead multidisciplinary CMC teams by working with internal CMC functions and external CDMOs. Interface with internal stakeholders including Analytical Development, Quality Management, CMC Regulatory, Procurement, and Legal, as well as external CDMOs, to ensure project success.
  • Establish drug product CMC development plans from project initiation through regulatory submission. Manage overall CMC budget for project development life cycle. Prepare monthly status reports for senior management. Represent CMC in core project teams to provide updates/escalation to governance bodies.
  • Evaluate and recommend CDMO selection based on its technical capabilities and quality systems. Lead strategy and execution of drug product development and manufacturing at CDMOs. Guide team in technical support to CDMOs for overall development and improvement. Resolve conflicts. Perform risk management evaluation and develop mitigation strategies.
  • Review and approve drug product development protocols and batch records. Review and approve technical drug product documents for regulatory submissions. Review and approve technical documents, reports and presentations for cross functional teams.

Requirements:

  • PhD or MS in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or relate field with 7-10 years of experience in the pharmaceutical industry working in drug product development at large/mid-size pharma companies.
  • Proven technical ability in developing new drug products, including formulation and process development, scale-up, technology transfer, and troubleshooting.
  • Significant experience working with drug product contract manufacturers including those in the US and Europe is required. Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship.
  • Ability to work/lead multi-disciplined teams to execute and achieve departmental and corporate goals. Strong project management experience with cross-functional team leadership and participation skills.
  • Superior interpersonal and communication skills (both written and oral) are essential. Experience working in a multi-cultural, multi-lingual environment is necessary with a demonstrated ability to contribute successfully in a multi-disciplinary team environment.
  • Requires expert understandings of formulation development, technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.
  • Self-motivated, able to work independently and be reliable and responsive.

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com

Location:

Parsippany


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Fuldtidsjob
Udlandet (øvrige)
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https://jobbank.dk/job/1365323/