Caring for the world, one person at a time… inspires and unites the people of Johnson & Johnson. We embrace research and science- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Post: Manager- Stability and Investigation Expert
• 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 PDMS CRS AD group at Higi, which is responsible for IND/CTA, NDA stability.
• Design and independently lead stability studies to support product development and investigations (using both ASAP (accelerated) and more traditional ICH approaches)
• Use predictive models and apply state-of–the art scientific knowledge to ensure innovative and high quality stability evaluation
• Work in a multidisciplinary team of researchers and show willingness to learn/explore innovative techniques and stability approach
• Act quickly and provide stability solutions and support projects from early to late development phase as stability expert
• Support scientifically projects and act as coach for younger scientists
• Apply state-of–the art scientific knowledge to ensure high quality delivery
• Follow-up literature in order to create new opportunities and stability approach
• Ensure compliance with all relevant regulations, guidance, compendial requirements for stability studies, analytical methods and specifications, GMP and safety
• Ability to manage teams and collaborate with excellent understanding of customers’ needs
• Responsible to meet 100% on time delivery of assigned project activities.
• Align with global stakeholders within PDMS and Janssen supply chain organizations to harmonize best practices and support partners to harmonize the lab processes as per the Janssen requirements.
• Technically strong and good understanding of analytical techniques such as chromatography, dissolution, moisture determination, particle size determination, spectroscopy, microbiology etc.
Key Interaction Areas: Extensive interactions with multidisciplinary and multi- site groups which primary include external strategic partners/ material owners, etc.
Quality & Compliance Responsibilities: Ensures quality and compliance following the GMP/ safety requirements and maintain related to assigned activities.
Education: MS Degree in Organic Chemistry, Pharmacy, or equivalent life sciences degree. Ph.D. is preferred.
Experience: At least 12 years in reputed pharmaceutical company (in Analytical function with proven scientific skills)
Functional competencies (Skills, Knowledge and Attributes):
• You hold a PhD degree in Organic chemistry or Pharmaceutical Sciences, or equivalent through experience.
• Good knowledge and experience analytical techniques required for drug substances and drug product characterization (LC, MS, dissolution, DSC, DVS, XRPD…)
• Knowledge of ASAP and DoE would be an asset
• Practical experience in pharmaceutical Industry in one or more of the above listed test parameters and GMP regulation is an asset.
• Ensure high scientific quality standards for experiments and ownership of work
• Efficient, flexible and dynamic
• Innovative solutions/problem solving skills
• You have project management experience
• You are customer-oriented and results-driven
• You have good knowledge of the English language, both spoken and written
• You have good technical writing skills
• You are able to work independently and are also a team player
• Embrace competencies needed to work in diverse teams and to ensure inclusion
• Knowledge of the quality systems like events, deviation, OOS/OOT, CAPA & change controls etc.
Behavioral Competencies (/Leadership Imperatives):
• Good team player having Self-confidence, ethics and values and analytical thinking capability
• 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.
Experience: 12 years
Location: Maharashtra-Greater Mumbai
Functional Area: R&D
Department: PDMS – Clinical Release & Stability
Industry Type: Pharma/Biotech/Clinical Research
Requisition ID: 1600078639W