Job Description:
Contract Scientist needed in the Technical Operations Large Molecule Global Team for a position of Drug Product Technical Owner/Technical Launch Integrator (New Product Introduction). This individual will be part of New Product Introductions.
The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place.
The TLI is a member of the manufacturing site operational teams, CMC DPD Sub team, and JSC New Product Team and leads the new production introduction team at the DP or DS site.
Key Responsibilities:
The TLI is a key function in New Product Introduction and is responsible for:
Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain (large and small molecule).
Leading the DP manufacturing site team and manufacturing site representative on the DPD Sub team and the JSC New Product Team.
Single point of contact for Janssen Supply Chain (JSC) plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support.
JSC technical input and technical acceptance of DP into the supply chain including cost and robustness metrics through a process of "touch points", thereby ensuring "one voice of the customer" towards R&D and consistency across projects and across plants.
Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SME's) into project execution and QbD technical implementation at the manufacturing site level.
Qualifications
Education:
Seven years of meaningful experience and BS degree or equivalent; Or 4+ years with advanced degree MS/MBA/PhD or equivalent.
Experience and Skills:
Required:
Strong project management skills with experience in supporting the execution of large-scale projects. You should have a sound sense of urgency, process-oriented skills, attention to detail, outstanding teaming and collaboration skills
Good communication skills including technical writing proficiency
A minimum of 7 years of experience and a BS degree, or advanced degree MS/MBA/PhD at least one area within these functions: Small Molecule and/or Large Molecule pharmaceuticals; research and development; Technical Operations; API/ Drug Product Manufacturing; Quality; Regulatory; Drug Development.
Ability to lead, encourage and coach project teams and individuals
The job requirements are specific and fast paced - candidates should have a technical & manufacturing background with a detailed aseptic processing understanding, good project management and interpersonal skills
She or he should also be able work with Health Authorities and technical representatives from Partners and Contract Manufacturers, and to provide answers to HA questions on regulatory documents, ensure technical PAI inspection readiness, etc.
Knowledge in process validation, equipment qualification and aseptic process equipment requirements
Lead multi-functional and third-party teams for complex investigations, Tech Transfer and process improvement projects.
General knowledge of the pharmaceutical industry
Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with working technical knowledge of GMP.
Knowledge of manufacturing site systems and procedures
Preferred:
Proven ability to partner and work with multiple departments and manage projects. Experience with technical transfers involving cross-functional, cross-geography, and cross-company teams
Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams.
Foster team efficiency and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
Influence peers, superiors, and partners.
Knowledge of both pharmaceutical product R&D and Technical Operations functions and experience with both small and large molecules.
Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
