Senior Technical Manager - API (DS)

Job Purpose  

Lead and manage all Manufacturing Science & Technology activities for the assigned

Contract Manufacturing Organizations (CMOs). This includes, providing product stewardship by ensuring the performance of all NVS products are monitored and maintained in a validated state, supporting root cause investigations by providing MS&T intelligence to  deviations,  technical  complaints,  OOS  &  CAPAs,  identifying  and  executing continuous improvement

opportunities.

Acts as the ESO Project Team Lead (PTL) for new product launch at CMO’s / technology transfer at CMO’s. Assembles and leads a cross-functional team to ensure the successful transfers of manufacturing at CMOs. Ensures appropriate project management to achieve milestones in time, with required quality and in budget by leading the respective technical sub-team and liaising efficiently with related functions.

Supports the MS&T organization by leading ESO-wide initiatives and/or work-streams and representing ESO MS&T in various global networks.

Major Accountabilities 

Product Stewardship
 

• As Product Steward, ensure that the products stay in a validated state and their technical
  performance/capability is monitored.

• Major accountabilities include:
  -  Assessing impact of manufacturing changes;
  -  Providing MS&T intelligence to deviations, investigations, OOE’s and OOS’s, technical
     complaints;
  -  Defining and tracking technical CAPAs resulting from APR/PQR assessments or
     manufacturing variances;
  -  Providing MS&T intelligence to APR/PQR and delivering the performance capability results,
     interpretations and recommended CAPAs;
  -  Identifying process optimization opportunities and executing them when approved;
  -  Identifying and leading product manufacturing remediations;
  - Establishing and executing product revalidation strategies including approval of QRAs,
     validation protocols and reports;
  -  Establishing and executing continued process verification strategies and annual verification;
  -  Ensuring maintenance of knowledge for the manufacturing of NVS products;

Product Transfers and New Product Launch

  • Leads a cross functional team for product transfers/launches to 3rd parties (process,
    technology, analytics, capacity, resources).

  • Ensures appropriate project management to achieve milestones in time, with required quality
    and in budget by leading the respective technical sub-team and liaising efficiently with related
    functions.

  • Provides technical expertise together with manufacturing experts.

  • Supports CMO site selection and ensure right technical fit for transfer/launch

  • Defines and monitors technical project scope, timing and progress in collaboration with Giving
    Site or TRD

  • Writes Manufacturing Process Transfer Documents (protocol, report).

  • Coordinates feasibility, regulatory and validation batches at site.

  • Initiates monitoring and Continued Process Verification CPV phase.

  • Ensures that all activities are performed to current standards (current Good Manufacturing
    Practices cGMP, Health Safety Environment HSE, Regulatory etc.).

  • Supports continuous process and quality improvements.

  • Supportd QA to ensure inspection readiness (Pre Approval Inspection PAI).

Key Performance Indicators 

• Technical transfer milestones achieved on time and in full, including schedule for registration and  launches.
• Robust manufacturing process at CMO, delivering critical quality attributes.
• Analytical methods in place, meeting cGMP standards.
• No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI). 
• Adheres to project / Capital Approval Request CAR costs.

• Recognized as an excellent collaborator and partner by the CMOs, SRTs, QA and others partner functions (R&D)
• When acting as Product Steward, meet related KPIs:
• Product is maintained in constant state of validation.
• Product history is documented and available and current since transfer from development/transfer to CMO to date.
• Recurring Deviations.
• Continuously improving CpK – process capability.
• Degree of standardization of product process
• OoS, OoE – Out of Specification, Out of Expectation.
• Customer Complaints.
• Recalls.
• Success rate of Health Authorities' inspections.
• Completeness of Reg CMC dossier
• Effective CAPA.
• Continuously improving Yield.
• Technical reports executed on time and with the right expectations.

Number of associates:

None (may have direct reports depending on Division)

Financial responsibility:

(Budget, Cost, Sales, etc.)

Impact on the organization:

Strengthen   product/process   manufacturing   performance, reducing product quality complaints.

Improve Supply Chain performance by increasing process robustness, minimizing recalls, rejected batches and write- offs.

High
Ensures that Novartis products manufactured at CMOs meet stay in a validated state, are trended and optimization potential are implemented.

Ensures Transfers and launches are executed according to
plan
Contribute to ESO Manufacturing financial /business/quality goals.
Minimize rejected batches and write-offs.
Maximize Yield improvements.

Ideal Background 

Education :

Language:

• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
• Highly desirable: Ph.D., MSc. or equivalent experience.

• Fluent in English

Experience:             

• 10 yrs of experience in a Pharmaceutical manufacturing/technical environment.
• Strong leadership skills with a minimum of 5 years managerial experience
• Demonstrated technical expertise in manufacturing science and drug development.
• Significant knowledge of industry practices and regulations (e.g. GxP, ISO, ICH / VICH, etc.) across multiple health authorities (e.g. FDA, EMEA, Health Canada, etc.)
• Statistical knowledge required, Lean/Six Sigma Certification preferred
• Demonstrated leadership and accomplishments in a global/matrix environment in the pharmaceutical industry
• Strong project management, interpersonal, cross-cultural, communication, negotiation and problem solving skills

Novartis Competencies

Leadership Standards

Fundamental

Intermediate

Advanced

Thought Leader Sets Clear Direction & Aligns Team & Others Around Common Objectives

Energizes The Team

Display Passion For The 3Cs

Exercises Good Judgement & Drives Change For Competitive Advantage

Drives For Superior Results & Has Passion To Win

Builds The Talent Pipeline

Inspires Continuous Improvement & Breakthrough Thinking

Displays Analytical & Conceptual Thinking

Functional Competencies

Fundamental

Intermediate

Advanced

Thought Leader

• Why Novartis:  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.