Senior Director, Biologics Drug Substance - Leadership Role

Employer
Celgene
Location
Summit, NJ
Posted
Apr 30, 2018
Ref
1800714
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- NJ- Summit West


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.

Senior Director, Biologics Drug Substance - Leadership RoleSummit, NJ

The Senior Direct of Drug Substance Development is a strategic and technical manager responsible for early and late stage process development and optimization, as well as late stage process characterization and validation of drug substance processes. In addition, this role oversees cell line development for our molecules. This individual is responsible for designing and executing studies to develop process control strategies for the pipeline molecules to support initial manufacturing and IND submissions. He/she will work closely with other development functions, including analytical, and formulation, CMC and collaborate with manufacturing, validation, quality and regulatory functions to support development of molecules leading to commercialization. This Senior Director will drive talent management processes focused on the selection and development of employees who to support these activities.

Summary of Position

The Senior Direct of Drug Substance Development is a strategic and technical manager responsible for early and late stage process development and optimization, as well as late stage process characterization and validation of drug substance processes. In addition, this role oversees cell line development for our molecules. This individual is responsible for designing and executing studies to develop process control strategies for the pipeline molecules to support initial manufacturing and IND submissions. He/she will work closely with other development functions, including analytical, and formulation, CMC and collaborate with manufacturing, validation, quality and regulatory functions to support development of molecules leading to commercialization. This Senior Director will drive talent management processes focused on the selection and development of employees who to support these activities.

Primary Responsibilities Include

  • Lead early stage pipeline programs, including process development, scale-up, toxicology material production, technology transfer, clinical material manufacturing support, and IND submissions, to support development of molecules leading to commercialization.

  • Define strategic goals and lead the efforts for late stage program strategies toward commercialization, including the design, coordination, and execution of process characterization and small and large scale validation studies.

  • Manage the screening, optimization, selection and creation of clonal cell banks.

  • Oversee the technology transfer of developed drug substance processes to internal and external GMP manufacturing sites.

  • Establish and qualify scale-down models to support characterization studies and cGMP manufacturing.

  • Author drug substance sections of IND, BLA, and other regulatory documents such as protocols and technical reports in collaboration with the development, quality, and regulatory groups to support regulatory filings.

  • Recruit, motivate, retain and develop key employees. Build and sustain employee engagement by creating an environment where individuals and teams can excel. Establish departmental and individual goals and objectives in alignment with corporate goals and priorities. Identify performance improvement targets and metrics.

  • Responsible for the department's annual budget and quarterly forecasting processes. Manage head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.

  • Create a high-performing team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.

  • Present scientific findings at internal and external meetings and champion scientific journal publications. Represent Celgene at meetings with collaborators

  • Serve as subject matter expert related to drug substance development , including all process and manufacturing related activities, risk assessments, characterization, investigations, regulatory interactions, and project team requirements.

  • Champion and implement business processes for continuous improvements and support continuous improvement culture & mentality within the organization. Actively engage in the identification, sharing and adaptation of best practices cross-functionally

    Preferred Qualifications:


  • Ph.D. with minimum 15 years of relevant experience preferred (BS or MS as well) in the corporate bio pharmaceutical industry with increasing scientific and leadership responsibilities.


  • Expertise in process development of complex biological products utilizing state-of-the-art techniques and multiple production platforms.

  • Experience building a high-performing team and mentoring scientists and engineers

  • Demonstrated ability to drive technological innovation and implementation in a clinical or commercial manufacturing environment

  • Strong knowledge of GMP and ICH requirements.

  • Results-driven with excellent attention to details

  • Demonstrate a sense of urgency, proactive thinking and multitasking are essential.

  • Excellent oral and written communication

  • Strong management skills and ability to coach and develop talents

  • Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions

  • Ability to lead successfully within extended, global multinational project teams and handle multiple challenges under pressure.

  • Demonstrated ability for innovative and big picture thinking.

  • Requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence.

  • Excellent communications and presentation skills - written and verbal; create and deliver presentations with appropriate messaging and focused recommendations

  • Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously

  • Negotiation and strong persuasive abilities, diplomacy and positive influencing abilities

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.