The Pharmaceutical Development & Manufacturing Sciences Organization (PDMS) of Janssen R&D,constituting of around 1200 people across the globe, aims to develop and bring products to the patients in a timely manner without delays. With a vision of 'One passionate team transforming molecules to medicines for patients worldwide' the PDMS Organization covers Active Pharmaceutical Ingredient (API) - Small Molecules, API - Large Molecules, Drug Product Development, Analytical Development, Portfolio Management, Clinical Supply Chain and Strategic Operations.
Clinical Release & Stability (CRS) is a department of PDMS within the Janssen R&D organization. The department is responsible for clinical release and stability testing of Drug Substance (DS) and Drug Product (DP) for small molecules covering Phase 1 through Phase 3, DS and DP manufacturing process and product characterization support and the stability process for small and large molecules in R&D.
This position is in one of the CRS group at Higi, which is responsible for IND/CTA, NDA stability along with clinical release from Higi Pilot Plant.
The roles and responsibilities of this position include:
Technical project delivery support within the CRS Organization by interfacing with key stakeholders
for all critical small molecule analytical projects to enable 100 % on time delivery.
Ensure participation and focused progress of Analytical development groups/projects and other
involved Technical integrator functions and facilities.
Support strategy to meet regional customer requirements in EMEA, Asia Pac and US as per guidelines.
Coordinate the execution of cross-site, cross-functional analytical deliverables, for method development, process scale-up, tech transfer, through late development.
Responsible for the output and quality for technical reports and regulatory documentation through the writing of technical analytical content for regulatory submissions.
Responsible for the resolution of Analytical project issues. In collaboration with technical integrators, Quality, and Janssen Supply Chain personnel, share responsibility for resolution of
clinical supply challenges as they pertain to Analytical initiatives.
Ensure alignment with stakeholders, early to late development and manufacturing for small molecules.
Able to support technical writing of amendments, annual reports, agency responses, and other submissions.
Responsible for providing input to TIs for authoring documents/dossiers as Analytical Technical Project lead.
Key Interaction Areas:
Extensive interactions with multidisciplinary and multi-site groups and technical integrators which may include external vendors and/or strategic suppliers.
Quality & Compliance Responsibilities:
Performs activities following the GMP/safety requirements related to the assigned activity.
Education & Certifications:
MS Degree in Analytical Chemistry, Pharmacy, or equivalent life sciences degree. Ph.D. is preferred.
At least 10 years of experience in reputed pharmaceutical company.
Functional competencies (Skills,Knowledge and Attributes):
General knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process.
Knowledge of analytical or biochemistry in a R&D environment.
Behavioral Competencies (Leadership Imperatives):
Technical and Project management skills, excellent writing and communication skills.
Ability to foster team productivity and cohesiveness in a complex matrix environment.
Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.
Ideal Profile would be a blend of Technical expertise along with Project management.
Knowledge and experience in the field of analytical development upto 3-4 years is good.(30%).
Similar is the expectation in the area of stability study at clinical and registration stage(40%)
Experience in Technical Project Management skills that includes technical knowledge of stability documentation (protocols/ reports), stability project coordination & interaction with stakeholders (Project sub-teams)(30%).