Associate Director, Manufacturing Operations Job
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Job Title: Associate Director, Manufacturing Operations
Job ID: 13076
Location: Basking Ridge, NJ -110
Full/Part Time: Full-Time
Category: Manufacturing/Tech Ops
Department: Manufacturing Development API - 3259
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
10 -15 years relevant experience in a related field, including 4 years of leading role in chemical synthesis, biologics or API manufacturing, planning, and outsourcing in the pharmaceutical industry.
PhD degree in advanced science (chemical or biochemical engineering, biology or chemistry)
A PhD degree may be substituted for 5years of related experience.
This position is responsible for the procurement of custom synthesis of APIs for preclinical and clinical development of new pharmaceutical products and commercial products.
Responsibilities will include, but are not limited to, the following:
The primary role of the Associate Director of Active Pharmaceutical Development (API) Development will be to lead and coordinate internal and outsourced development of API manufacturing processes for Celgene pipeline products. This position will supervise and/or play a central role in the planning and execution of projects to advance the development of the Company’s product candidates. Products may be for Pre-Clinical, investigational use, clinical supplies, or commercial sale. The responsibilities include:
1. Define, develop and implement API processes and development strategies based on scientific, technical, regulatory, and market place needs.
2. Lead transfer of new technology from Process R&D to Manufacturing Facilities for commercial and development compounds. Develop project plans which define timing, resources and overall project costs.Responsible for production schedules based on clinical API requirements.
3. Evaluate, recommend and oversee contract manufacturing organizations capable of providing the technical services required. Ensures suitable quality, optimal economics, and adequate supply chain security for commercial and clinical products.
4. Direct, coordinate, and execute product, process optimization, and validation studies using Quality by Design principles. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
5. Act as the primary contact/representative to internal and external clients for dosage form development on specified projects. Responsible of API supplies to support safety, development and clinical studies for multiple projects.
6. Lead multifunctional technical development teams on specified projects. Lead the resolution of technical issues related to development and commercialized products. Confers with contract vendors and analyzes vendors' operations to determine factors that affect prices and determines lowest cost consistent with quality, reliability, and ability to meet required schedules.
7. Coordination of project activities with other internal functions such as Regulatory Affairs, Quality Assurance, Analytical R&D, Preclinical and Clinical functions, Sales/Marketing, etc.
8. Author, review and approve CMC related documentation as required for the market application. Interact with FDA/EMA regulatory authorities pre- and post-submission as required. Ensures all regulatory requirements are met in the Technical Operations and Contract Manufacturing Facilities
9. Collaborate with Process R&D and Pharmaceutical Product Development and AR&D with a primary focus on final drug product dosage form/delivery systems while providing input into requirements for drug substance, and analytical methods.
10. Assure timely delivery of adequate supplies of APIs and precursors to meet project needs and identify and qualify sources of starting materials, intermediates, and APIs
11. Establish suitable agreements covering confidentiality, supply terms & conditions, and quality agreements
12. Monitor and troubleshoot key manufacturing activities, approve batch records and site visits
timely communicate risks and delays to project teams.
1. Broad based knowledge of API chemical and API development and manufacturing.
2. Solid experience in API development with demonstrated expertise in small molecule development.
3. Understanding of drug substance characterization and impact on drug product development.
4. Ability to evaluate, and share data across functions for evidence based decision making.
5. Proven ability in chemical synthesis development and process improvements.
6. Development and validation of manufacturing processes.
7. Lead, and participate in technology transfer activities.
8. Strong communications skills with a team oriented approach.
9. Project Management skills including the ability to prioritize, schedule and manage multiple projects and resources simultaneously. Sound organizational and time management skills.
10. Working knowledge of international GMP requirements and quality systems.
11. Working knowledge of current regulatory guidelines (EMA and FDA).
12. Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation.
13. PhD in Chemistry, Biochemistry, or Biochemical/Chemical Engineering. A PhD degree may be substituted for 5years of related experience.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
Deadline: Contact employer
For more details
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