Department: PDMS - Clinical Release & Stability
Division/ Sector: Janssen
Reports To: Director --CRS-AD
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 from the outsourcing partners' site to 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 are transcribed onto partners site.
Support strategy at partners site such as to meet Janssen organisation requirements as per
compliance is met.
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 and lead QC-analytical activities at
CRO/CMOs including release and stability testing, analytical methods transfer, qualification,
validation and implementation.
Routinely interface with PDMS Analytical Development, Business Development units,
Formulations, Regulatory Affairs, and Quality Assurance to meet demand supply gap control
needs across multiple programs.
Extensive interactions with the SPOC, functional Project leads such that lab is virtually available.
Ensure alignment with stakeholders, early to late development and manufacturing for small
molecules, such that the same is executed at partner sites
Responsible for providing input to Project leads such as working as an extended arm for
Analytical Technical Project lead at partners' site.
Collaborating with the QC and Microbiology department of the Partners site so as to give virtual
visibility to CRS Director on the analytical schedule, equipment use, investigations and analytical
method trouble shooting.
This role requires frequent (nearly 66%) travel to CROs (Bangalore, within Mumbai)
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.
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.