Senior Specialist, Project Management

Job Description

Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench to Good Manufacturing Practice (GMP) manufacturing facilities, our scientists and engineers use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients. The External Development and Manufacturing (ExDM) team within PSCS is focused on executing our Company's Research Laboratories drug product sourcing strategy across all phases of small and large molecule research and development operations.

The successful candidate will be accountable for managing the execution of formulation development and cGMP drug product batch manufacturing campaigns at external providers as part of a matrix team including product development teams and internal partner groups (quality, analytical, procurement, and global clinical supply). Projects may include solid oral dosage forms (tablets, capsules), sterile injectables, or specialty dosage forms (inhaled, implants) delivering small molecules, biologics or vaccines. They will also design and implement strategies to realize new manufacturing technologies and dosage forms using the external network.  The candidate will also have opportunities to improve business practices and work with project teams on the technical aspects of products in development.  The successful candidate will have relevant advanced experience and/or significant relevant practical experience in the pharmaceutical industry.

Additional job duties include:

• Outsource and coordinate formulation development and/or clinical manufacturing at Contract Research Organization (CROs)/Contract Manufacturing Operation (CMOs)

• Manage vendor relationships and maintain an understanding of current vendor capabilities in the pharmaceutical industry

• Provide manufacturing and compliance expertise to project teams

• Support Pharmaceutical Sciences technology development efforts by sourcing external services such as equipment trials, research collaborations, software trials, etc.

• Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area; bring knowledge and creativity to the position as well as have the discipline to drive results

• Identify and champion continuous improvement projects for the workflows within the group

• Collaborate effectively with critical partner groups such as Procurement, Quality and Global Clinical Supply (GCS)

Note: This position is available either in Rahway, NJ or West Point, PA based on candidate preference.

Education:

• B.S. degree in Chemical Engineering, Pharmaceutical Sciences or related field with five (5) years relevant industrial experience

• M.S. degree or higher education in Chemical Engineering, Pharmaceutical Sciences or related field with three (3) years relevant industrial experience

Required Experience and Skills:

• Prior experience with development and/or manufacturing of drug products/drug substance or relevant technical experience

• Ability to work effectively with team members of diverse skill sets and backgrounds

Preferred Experience and Skills:

• Hands-on experience in pharmaceutical pilot plants

• Knowledge of cGMP requirements for drug product manufacture

• Direct experience of working with external suppliers

• Project management experience

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advis