Director, Biologics Manufacturing

Employer
Celgene
Location
Summit, NJ, US
Posted
Nov 09, 2018
Ref
1803343
Required Education
Bachelors Degree
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Director, Biologics Manufacturing - Drug Substance
Summit, NJ

SUPERVISOR: Executive Director, Biologics Manufacturing

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

POSITION SUMMARY

This position is responsible for the selection and management of Contract Manufacturing Organizations (CMO's) by directing the manufacturing activities of biologic drug substances through the various stages of late stage clinical development and commercial manufacturing. This includes providing leadership in the development and execution of drug substance development programs to successfully support regulatory submissions, BLA approvals as well as routine commercial manufacturing. Additional responsibilities include direct oversight of contract organizations performing biologics process, analytical and formulation development, manufacturing and testing activities. Working as a key member of the Biologics Development and Manufacturing organization, the candidate will be responsible to maintain a successful manufacturing supply chain by contributing to all aspects of manufacturing including process development, technology transfer, batch manufacture, release and logistics.

RESPONSIBILITIES
  • Provide direct oversight of CMOs including project scope development, contract negotiation, budget/timeline development, managing the quote/approval process and ensuring cost containment throughout
  • Identify, recommend, and build collaborative working relationships with process/analytical/formulation development and manufacturing contract organizations
  • As a key technical and operational interface for CMO management, lead and manage development projects through the CMOs. Key responsibilities include:
    • Provide leadership in resolving complex technical and operational problems
    • Ensure scalable, commercially-viable biological manufacturing processes are transferred, implemented and validated as necessary
    • Manage strategic and tactical decisions related to equipment selection and process design
    • Ensure sufficient quantities, quality and timeliness of deliverables
    • Provide person-in-plant (PIP) support for critical manufacturing operations
    • Oversee the creation/approval of cGMP-compliant documentation (e.g. master batch records, SOPs), as well post-manufacturing review and close-out of executed batch records and other batch release documents
    • Assist in deviation/OOS investigations, determination of root cause, and implementation of appropriate CAPA
    • Manage budgets, schedules, and performance requirements to meet project goals
  • Participate in or lead cross-functional teams, and represent manufacturing on various project teams responsible for meeting short-term and long-term organizational goals.
  • Establish and communicate key project milestones and critical decision points for endorsement by senior management; report regularly on progress and potential risks to program objectives.


Qualifications:

Education & Experience
  • BS/MS in Pharmaceutical Sciences, Chemical Engineering or Biological Sciences with 15+ years' experience in Pharmaceutical industry, or equivalent. Ph.D. with 3-5 years' relevant experience with a strong preference for at least 5+ years managing contract organizations
  • Demonstrated technical proficiency in biologic drug substance processes (particularly monoclonal antibodies); including both upstream (mammalian cell culture, bioreactor operations) and downstream purification operations (centrifugation, filtration, UF/DF, chromatography unit operations) to Phase 3/commercial scale
  • Direct experience preparing and reviewing CMC documentation for regulatory filings and inspections
  • Cost of goods analysis, capacity evaluations and cycle time optimization skills preferred Prior experience working with ex-US business partners, and familiarity with ex-US Regulatory guidelines preferred
  • Demonstrated ability to proactively evaluate and independently develop solutions to complex problems
  • Ability to effectively manage multiple responsibilities, tasks, projects, and support staff simultaneously
  • Demonstrated project management and team facilitation skills


Knowledge Requirements:
  • Extensive knowledge of cGMP, ICH, FDA and EMA guidelines, and familiarity with global Regulatory requirements
  • Proficient in standard analytical techniques used in the biopharmaceutical industry
  • Competency in Microsoft Word, Excel, and PowerPoint; familiarity with Microsoft Project


Personal Competencies:
  • Ability to effectively manage multiple responsibilities, tasks, and projects simultaneously in a fast-paced environment.
  • Excellent oral and written communication skills. Ability to communicate clearly, and to present experimental results and analysis, and persuasively present recommendations.
  • Effective interpersonal skills. Ability to work in a team-oriented, cross-functional environment, and effectively manage diverse personalities and styles.
  • Demonstrated ability to proactively evaluate and independently develop solutions to complex problems
  • Self-motivated, independent, and results-oriented with initiative to complete tasks independently. Capacity to organize assignments and work within deadlines
  • Ability to work effectively in as a team player in a complex, changing environment; intensely committed to success and getting the job done well in a dynamic environment
  • Strong analytical and organizational skills; highly attentive to details
  • Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.

    Other Information
  • Travel: Up to 25% of the time - occasional international travel to partner and/or contractor facilities

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.

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.