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Operations

Senior Manager, MSAT Small Molecule Drug Substance External Manufacturing

  • 타이틀 Senior Manager, MSAT Small Molecule Drug Substance External Manufacturing
  • 부서 Operations
  • 하위 기능 Contract Manufacturing
  • 위치 Greater Mumbai, Maharashtra, India
  • 게시
  • 참조 2306111213W
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Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas.

Position summary:

This role is to provide site technical ownership at prioritized EMs and to closely work with internal/external partners to deploy life cycle management (LCM) and new product introduction (NPI) plan in line with product roadmap and supply chain strategy.

By closely working with key business partners from Partnership & External Supply (PES), Quality, Procurement, Value Chain Management (VCM), R&D, EHS and MSAT functional teams, this role will actively participate and contribute to different stages of supplier management.

A. Site Selection: Support technical assessment and evaluation

l On-boarding: Support process-fit-to-plant (PF2P) and technical transfer

l Engage: Lead (or support) technology deployment at EM sites according to Product Roadmap and provide on-site support for technical escalations/Investigations

B. Disengage: Support disengagement strategy

PRINCIPAL RESPONSIBILITIES:

  • Be the primary contact for technical issues related to assigned CMO sites and be a key member of Virtual Management Team (VMT).
  • Closely working with Technical Owner and (or) Technical Launch Integrator (TLI) to accomplish site-to-site technical transfers and be responsible for site activities of registration and validation campaigns.
  • Promote “Smart Technology Transfer” concept and coach suppliers to deploy as per Janssen best practices.
  • Develop good understanding of current status of ongoing and future planned technical activities at the site.
  • Bring technical insights to deviation investigation & technical issue escalation within VMT to assure timely resolution.
  • Coach and support EMs to handle troubleshooting / investigation with profound process understanding.
  • Maintain and follow up action log with observations / suggestions to drive manufacturing excellence by improving operation/process efficiency, process robustness and intensity.
  • Coach and support suppliers performing process data analysis, process modelling (with Global SME support) and statistical process control in order to characterize process capability and to increase process understanding.
  • Follow-up/review/approve documents ( e.g. , protocol, report, batch record) upon request.
  • Evaluate supplier-initiated change initiatives from technical perspective.
  • Owner of technical section in Account Plan for assigned EMs and engage other MSAT roles at the site to keep corresponding part updated.
  • Monitor and communicate supplier performance against established metrics. Develop and follow up improvement plans for supplier performance in collaboration with PES team.
  • Participate at annual strategy meeting with PES Site Lead and CMO management to discuss long-term strategy for the site.

자격

Knowledge skill and ability requirements:

  • 10-15 years’ experience in a cGMP API manufacturing environment.
  • Experience in developing/ introducing/scaling-up chemical processes and managing/overseeing commercial production
  • Good project management skills in process know-how transfers.
  • Statistical skills required to perform process data analysis/process modelling/SPC.
  • Deep understanding of typical unit operations and related process equipment
  • Trouble-shooting experience/ Affinity with related methodologies.

Must have cross-cultural mindset

Must be highly skilled at collaboration and comfortable working in a matrix organization.

Degree:

Minimum requirements: University Degree. Desire MSc or PhD in Chemistry / Chemical Engineering / Biotechnology / Pharmaceutical Science, etc.

Languages:

Fluent in written and spoken English.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

Works in an international environment across different time zones

Travel: Minimum 20-25 days per month (project dependent)

This role is open for remote working but with a base location of Mumbai thus the given incumbent will need to travel to Mumbai when required.

Are you ready to impact the world?

Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job