Talent.com
Manager 2 - Technology Transfer

Manager 2 - Technology Transfer

eTeam IncGreenville, North Carolina, United States
30+ days ago
Job type
  • Temporary
  • Quick Apply
Job description

Pay Rate : $37 - $41 / Hour

12 months contract

This role is for an SME in aseptic drug product manufacturing who will be responsible to lead the coordination of activities to transfer the drug product fill-finish process to the manufacturing site. The process consists of compounding, filling, and optical inspection. In this role the incumbent is charged with leading complex Technology Transfers and Process Performance Qualification (process validation) that drive reliability and sustainability of our products at external manufacturers.

This person will provide the technical insight and team leadership role to effectively deliver qualification of equipment, methods, hold times, and manufacturing processes aligned with the supply chain network strategy. This role will partner with External Manufacturers and client Innovative Medicine Quality, Planning, and Partnership & External Supply. The team will ensure processes are flawlessly introduced into the supply chain network and ongoing production consistently satisfies quality and regulatory needs.

The incumbent must be able to :

  • Work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in-depth evaluation of factors in multifunctional areas
  • Communicate efficiently with their core team
  • Influence other functions / levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties.
  • Travel to the manufacturer(s) as needed to provide on-site support or oversight, especially during production of qualification batches.

The incumbent should be an expert in biologic drug product manufacturing processes. Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable.

Process validation knowledge for pharmaceutical ingredients or products is desirable.

Domestic travel to manufacturing site required, up to 25%. (Travel to Greenville, NC about 1x a month with short notice).

Tasks and responsibilities

  • Lead complex technology transfers with a focus on right-first-time execution and risk management.
  • Perform as SME to identify technical areas for improvement, and supply chain improvement
  • Lead drug product Process Performance Qualification and preparation of regulatory reports.
  • Support the internal and external teams to ensure manufacturing site readiness, reliability and sustainability.
  • As needed, provide SME input on complex investigations, root cause identification, product impact assessment and corrective and preventive actions implementation.
  • Represent J&J Innovative Medicine Supply Chain in interfacing with external manufacturing company.
  • Manages international sample shipments, execution of shipping route verification studies per SOPs, supports investigations and CAPAs as technical expert in the Drug Product manufacturing process.
  • Reviews and approves batch records, validation protocols, data, and reports.
  • COMPETENCY (knowledge, skills, abilities and experience required) :

    Specific knowledge :

  • Proven track record in in at least three of these areas :
  • Project leadership
  • Pharmaceutical process development
  • New product introduction
  • Technology transfer
  • Process validation
  • Production support.
  • Demonstrated technical competency and experience with biologic drug product
  • Demonstrated experience in managing technology transfers and / or Life Cycle Management projects and investigations.
  • Partnering with R&D and JSC groups to improve the fit for plant and commercialization of new products into the supply chain.
  • Personal and interpersonal skills / Leadership skills
  • Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.
  • Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level.
  • Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
  • Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.
  • Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
  • Ability to manage complexity and change.
  • Personal attitude and mindset
  • Motivated, self-starter able to work independently with demonstrated problem solving skills.
  • Drives for innovation and change to ensure competitiveness.
  • Can-do mentality : takes initiative, creates a result-oriented working spirit in his / her team.
  • DEGREE :

  • Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals, or Bachelors + 8 years
  • LANGUAGES :

  • Fluent in written and spoken English
  • PHYSICAL REQUIREMENTS / WORKING CONDITIONS :

  • Works in an international environment across different time zones
  • Travel : ~25% of time based on role and specific business goals
  • Virtual Network interactions, utilizing available infrastructure to communicate with Key Partners and Stakeholders
  • Create a job alert for this search

    Manager Technology • Greenville, North Carolina, United States

    Related jobs
    • Promoted
    VDC / BIM Manager - HVAC - Remote Option (Greenville)

    VDC / BIM Manager - HVAC - Remote Option (Greenville)

    CyberCodersGreenville, NC, US
    Remote
    Part-time
    Top ENR Mechanical contractor is looking for experienced HVAC and piping VDC Managers and technicians to join our growing team. The ideal candidate will play a crucial role in supporting the coordin...Show moreLast updated: 8 days ago
    • Promoted
    Operations Planning Senior Manager

    Operations Planning Senior Manager

    Victra - Verizon Wireless Premium RetailerWinterville, NC, US
    Full-time
    Operations Planning Senior Manager.Victra is Verizon’s largest premium retailer in the United States.We thrive on collaboration, innovation, and performance. Our mission is to “Connect t...Show moreLast updated: 12 days ago
    • Promoted
    Sr R&D Project Manager

    Sr R&D Project Manager

    Thermo FisherGreenville, NC, US
    Full-time
    The Senior Project Manager demonstrates advanced project management capabilities and life sciences industry knowledge in order to drive the manufacturing or packaging process transfer or analytical...Show moreLast updated: 30+ days ago
    • Promoted
    Communication & Change Manager

    Communication & Change Manager

    ALTEN Technology USAKinston, NC, US
    Full-time
    Communication & Change Manager.We're ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to lifefrom advancing space exploration and life-saving medical devices ...Show moreLast updated: 5 days ago
    • Promoted
    Operations Engineering Management

    Operations Engineering Management

    Spirit AeroSystemsKinston, NC, United States
    Full-time
    Spirit AeroSystems designs and builds aerostructures for both commercial and defense customers.With headquarters in Wichita, Kansas, Spirit operates sites in the U. The company's core products inclu...Show moreLast updated: 5 days ago
    • Promoted
    Sr. Prod Engineer Plastics - Rocky Mount, NC

    Sr. Prod Engineer Plastics - Rocky Mount, NC

    Hubbell IncorporatedRocky Mount, NC, United States
    Full-time
    Support designated product line in the areas of product development, product line maintenance, production release, production support, and product applications. This position will require working wi...Show moreLast updated: 30+ days ago
    • Promoted
    Engineering Manager

    Engineering Manager

    Associated Materials InnovationsKinston, NC, United States
    Full-time
    Engineering Manager - Kinston NC based.Since 2022, Associated Materials / Alside has been undergoing a transformation to maximize our potential through investments in people, operations, and brands...Show moreLast updated: 13 days ago
    • Promoted
    VDC / BIM Manager - HVAC - Remote Option

    VDC / BIM Manager - HVAC - Remote Option

    CyberCodersGreenville, NC, United States
    Remote
    Full-time
    Top ENR Mechanical contractor is looking for experienced HVAC and piping VDC Managers and technicians to join our growing team. The ideal candidate will play a crucial role in supporting the coordin...Show moreLast updated: 13 days ago
    • Promoted
    Continuous Improvement Engineer

    Continuous Improvement Engineer

    JobotPinetown, NC, US
    Full-time
    Continuous Improvement Engineer Role with Industry Leader / $75,000 - $95,000 per year depending on Experience / Excellent Benefits and Room for Growth. This Jobot Job is hosted by : Ken McClure.Are ...Show moreLast updated: 13 days ago
    • Promoted
    Vice President of ICF Operations

    Vice President of ICF Operations

    RHA Health Services, LLCLa Grange, NC, US
    Full-time
    Vice President of ICF Operations.We are hiring for : Vice President of ICF Operations.If you are a positive and personable individual looking for a satisfying and fun opportunity to make a real diff...Show moreLast updated: 30+ days ago
    • Promoted
    Vice President of ICF Operations

    Vice President of ICF Operations

    RHA Health ServicesLa Grange, NC, US
    Full-time
    Vice President of ICF Operations.We are hiring for : Vice President of ICF Operations.If you are a positive and personable individual looking for a satisfying and fun opportunity to make a real diff...Show moreLast updated: 30+ days ago
    • Promoted
    Engineered Solutions Project Manager

    Engineered Solutions Project Manager

    Daikin AAFWashington, NC, US
    Full-time
    AAF International offers the most comprehensive clean air solutions available across the globe.Selling under the American Air Filter and the AAF International brand names, AAF International has bee...Show moreLast updated: 19 days ago
    • Promoted
    Engineering Manager (Kinston)

    Engineering Manager (Kinston)

    Associated Materials InnovationsKinston, NC, US
    Part-time
    Engineering Manager - Kinston NC based.Since 2022, Associated Materials / Alside has been undergoing a transformation to maximize our potential through investments in people, operations, and brands...Show moreLast updated: 8 days ago
    • Promoted
    Special Projects CEO (LNHA)

    Special Projects CEO (LNHA)

    Signature HealthCARE, LLCKinston, NC, US
    Full-time
    Executive Director, Licensed Nursing Home Administrator (LNHA), Area Leader –.Be a part of the forthcoming “.Where we can’t stick with the status quo; it’s time for a change...Show moreLast updated: 30+ days ago
    • Promoted
    Engineered Solutions Project Manager

    Engineered Solutions Project Manager

    American Air Filter InternationalWashington, NC, US
    Full-time
    AAF International offers the most comprehensive clean air solutions available across the globe.Selling under the American Air Filter® and the AAF International® brand names, AAF Internation...Show moreLast updated: 18 days ago
    • Promoted
    Side Hustle Project Lead

    Side Hustle Project Lead

    Finance BuzzPinetops, North Carolina, US
    Full-time +1
    We’re offering a role for someone who wants to lead their own side-income project in their spare time.You’ll explore various proven side hustles, select the ones that fit your lifestyle, and run th...Show moreLast updated: 4 days ago
    • Promoted
    Connectivity Solutions Consultant (Hiring Immediately)

    Connectivity Solutions Consultant (Hiring Immediately)

    OptimumGreenville, North Carolina, US
    Full-time +1
    Are you looking to Optimize your life? Start your exciting path to a rewarding career today!.We are Optimum, a leader in the fast-paced world of connectivity, and we're on the hunt for enthusiastic...Show moreLast updated: 8 days ago
    • Promoted
    Chief Engineer

    Chief Engineer

    Hampton Inn GreenvilleGreenville, NC, US
    Full-time
    Reports to – General Manager.As Chief Engineer, you’ll ensure all aspects of the hotel’s engineering are kept to the very best standards and in line with all relevant health and s...Show moreLast updated: 30+ days ago