CMC Project Manager
Proclinical is currently recruiting for a REMOTE CMC Project Manager with a pharmaceutical company.
- Develops expertise to become SME for drug product GMSci organization and network
- In depth and broad (AD), solid (Sr Mgr), basic (Sr Professional, Professional) understanding of drug product manufacturing technologies for solid oral dosage form and/or injectible products
- Knowledge of industry's best practice and innovative/emerging technology with manufacturing of drug product (AD). Good grasp (Sr Professional), Acquiring (Professional) of industry's standard practices.
- Ability to influence within the organization, specifically with Pharmaceutical Sciences, GMS Operating Units and CMOs to drive decisions, alignment, and conflict resolution for complex cross-functional issues.
- Effectively communicate and implement innovative and emerging technology for drug product within the Manufacturing Sciences organization.
- Able to communicate and influence decisions of Pharmaceutical Sciences development organization.
- Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving).
- Able to independently make complex and key decisions impacting drug product manufacturing ogranzations (AD). Able to make decisions impacting the organization upon consultation with senior management (Sr. Mgr). With appropriate guidance, able to implement the decisions (Sr Professional, Professional).
- Active engagement with development product implementation prior to commercialization to ensure successful commerciallization of key products.
- Actively partner with local Manufacturing Science lead/reports to ensure consistent application of best techology practices across network.
- Ensures process knowledge sharing across sites and functions for effective management of products.
- Maintain current industry leading technology knowledge, scientific approach and regulatory strategies.
- Ability to drive and implement innovative technology at Local Manufacturing Science organizations.
- Manages with a matrix of reporting lines and across functional areas.
- Provides leadership to drive highly complex projects including that span multiple sites and products.
- Acccountable for successful collaboration with other functions within GMS, manufacturing Science Operating Unit staff, pharmaceutical Sciences counterparts, other key functional groups such as Global Quality, Regulatory CMC, etc.
Skills and Requirements:
- BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline with 15+ (AD), 10+ (Mgr), 5 (Sr Professional), 0 to 2 (Professional) years of industrial experience or equivalent.
- Minimum 5 (Mgr) years experience in pharmaceutical development and manufacturing
- Previous experience in serving as a SME lead in a matrix environment relating to drug product manufacturing. (N/A Professional level)
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.