Job Description

Director, Biologics Process Development

Our team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director, Biologics Process Development (BPD) within the Biologics Process Research and Development (BPR&D) organization is responsible for designing and implementing novel bioprocess technology platforms and processes for upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be a member of the BPD Leadership Team and directly responsible for a team of approximately 10-15 scientists and a portfolio of approximately 3-6 programs at various stages of development. The key accountabilities include managing the work and personal development of direct reports while effectively interacting with other teams within BPD and staff in Process Cell Science, US Operations, Clinical Manufacturing, and Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external partners for timely execution of work.

The successful candidate is expected to collaborate in a fast-paced, multidisciplinary, and highly matrixed team environment. The candidate is expected to be experienced in mammalian cell culture or purification process development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, and developing personnel under her/his/their supervision. The leader will maintain a strong network internally and will advance a culture of scientific excellence and compliance with the company's procedures for recording time, data entry, and trainings. The successful candidate will serve as a sounding board for facilitating decision making, will be skillful in managing people, and will be accountable for talent development of individuals in her/his/their direct team. Finally, the candidate is expected to possess an innovative mind-set and proven technical credentials through external presentations and publications.

Minimum required education: Ph.D. in Biochemistry, Biologics Sciences, Chemical Engineering, or related field with 10+ years of relevant experience in the pharmaceutical industry; MS with 13+ years of relevant experience; BS with 15+ years of relevant experience.

Required experience and skills:

• Experience in and good technical knowledge of biotherapeutic process development (including in cell line, upstream or downstream areas) or manufacturing is required; ability to project achievable project plans to ensure effective and timely execution is essential.
• Demonstrated ability in leading individuals with proven talent development skills.
• Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, program risks and mitigation strategies. In-depth knowledge in upstream cell culture process development or/and downstream protein purification development to support development of pipeline projects, platforms, and innovative technologies.
• Proven track record of authoring and providing critical input to the regulatory submissions including but not limited to Investigational New Drugs, Investigational Medicinal Product Dossiers, and Clinical Trial Applications.
• Ability to work closely with cross-functional stakeholders to ensure the team alignment with functional objectives.
• Ability to communicate program progress, issues, and mitigation plans to the senior management.
• Innovative mind-set demonstrated by technical accomplishments, external presentations, and publications.

The salary range for this role is $169,700.00 - $267,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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