Jobs
>
Billerica

    Associate Director of Manufacturing - Billerica, United States - Lantheus

    Lantheus
    Lantheus Billerica, United States

    6 days ago

    Default job background
    Description


    The objective of this position is to provide leadership and management oversight of cold (non-radioactive) product manufacturing technical operations on the Billerica Campus, while ensuring compliance with all GMP, OSHA and other regulatory requirements.

    The Associate Director (AD) leads the manufacturing operations to deliver on-time production of high-quality pharmaceutical product.

    The AD Manufacturing is responsible for leadership of a cross-functional team supporting the DEFINITY value stream operations (formulation, filling, inspection, and packaging).


    A key success factor for the AD Manufacturing is communication, coordination and partnership across the functions supporting GMP operations, including chairing the DEFINITY Site Leadership team.

    The Lantheus technical operations organization utilizes a tiered accountability model in which the AD Manufacturing participates at the Tier 1 and Tier 2 level, ensuring achievement of KPIs and effective resolution of escalations.

    The AD Manufacturing is responsible to set expectations for compliance with internal and external guidance, technical assessment of the processes, innovation, and reliability.


    Essential Functions:
    Upholds, fosters, and demonstrates the Lantheus core values:

    Let people be their best

    Respect one another and act as one

    Learn, adapt and win

    Know someone's health is in our hands

    Own the solution and make it happen

    Establishes programs, practices, and processes to drive a high-performance culture and an engaged workforce.

    Ensures value stream goals and metrics meet or exceeding expectations.

    Leads the DEFINITY Site Leadership Team including key partners from:

    Environmental Health & Safety (EH&S)

    Quality Assurance (QA)

    Quality Control (QC)

    Manufacturing Science & Technology (MSAT)

    Engineering and Facilities

    Validation

    Supply Chain

    Actively promotes safety rules and awareness, always demonstrating good safety practices.

    Takes initiative to prevent and correct safety & environmental hazards.


    Builds strong relationships with Quality Assurance and Quality Control, ensuring a culture of compliance with specific attention to risk-based decision making.


    Obtains and disseminates knowledge of product, equipment and process with business partners in MT&D, Engineering and Validation, to build deep organizational strength.


    Partners with Supply Chain Planning to establish the long-term production plan, ensure materials availability for production and is accountable to achieve the production schedule.

    Manages and delegates to ensure manufacturing supervision independently identify deficiencies, the create and executes action plans to mitigate issues.

    Actively promotes a productive and cooperative environment by empowering resources to set and achieve goals together.

    Develops stretch goals and uses effective motivation techniques to achieve them.


    Leads and/or participates as a team member on major deviations, investigations and CAPA, making sure that root cause is accurately identified and effective CAPA are implemented.

    Is accountable for the performance of all reporting team members.

    Establish and maintain the training curriculum for direct reports, as required by all internal policies and external regulatory agencies. Employ training and developmental programs to further enhance technical and organizational skills necessary to support growth objectives.

    Provide coaching, mentoring and development of staff and provides meaningful and actionable feedback for staff growth and development.

    Executes all phases of the performance review process with diligence and on time.

    Executes administrative functions to oversee the group.

    Effectively controls expenses (OT, Supplies, T&E) within their team.

    Mastery of managing resources to perform work in accordance with SOPs and cGMPs and consistently exceed first-pass quality benchmarks.

    Extensive knowledge of pharmaceutical manufacturing process with a proven record in technology transfer, process development, manufacturing support.

    Drives continuous improvements through staff engagement.

    Ensures shift continuity by maintaining daily/weekly/monthly staff meetings.

    Typical Minimum Skills and Experience and Education:


    Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.

    A master's degree in engineering, business administration or biotechnology is preferred.

    10+ years of experience leading operational personnel in routine or project settings.

    Minimum of 2 years of experience in a regulated manufacturing environment

    Other Preferred Knowledge and Skills:
    Provides direct audit support.

    Acts as a consultant to project teams.

    Able to effectively lead cross functional teams.

    Effective verbal and written technical communication skills are a must.

    Demonstrated aptitude for engineering principles and manufacturing systems.

    Operations that the AD is accountable for include:

    Automatic Parts Washers

    Parts and product sterilizers

    Vial Washers

    Depyrogenation Ovens

    Isolator based Automated Vial Filling Equipment

    Formulation Tanks

    Automated inspection, labeling and packaging equipment

    Computerized systems (SAP, QMS, Maximo, etc.)


    Routinely scheduled work, and or overtime work required on evenings, weekends, and or holidays and, even in adverse weather conditions.

    See Essential Personnel Policy.

    Non-routine overnight travel required based on business need.

    Routine and or frequent lifting; with reasonable accommodations.

    Demonstrates a detailed understanding of MRP and inventory control systems and processes.

    #J-18808-Ljbffr
  • Viridian Therapeutics, Inc

    Director, External Manufacturing

    1 week ago

    Viridian Therapeutics, Inc Waltham, United States

    : · At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-dri ...

  • Lantheus

    Associate Director of Manufacturing

    22 hours ago

    Lantheus North Billerica, United States

    The objective of this position is to provide leadership and management oversight of cold (non-radioactive) product manufacturing technical operations on the Billerica Campus, while ensuring compliance with all GMP, OSHA and other regulatory requirements. The Associate Director (A ...

  • Lantheus Medical Imaging Inc

    Associate Director of Manufacturing

    3 hours ago

    Lantheus Medical Imaging Inc North Billerica, United States

    Job Description · Job DescriptionThe objective of this position is to provide leadership and management oversight of cold (non-radioactive) product manufacturing technical operations on the Billerica Campus, while ensuring compliance with all GMP, OSHA and other regulatory requir ...

  • Lantheus

    Associate Director of Manufacturing

    1 week ago

    Lantheus North Billerica, United States

    The objective of this position is to provide leadership and management oversight of cold (non-radioactive) product manufacturing technical operations on the Billerica Campus, while ensuring compliance with all GMP, OSHA and other regulatory requirements. The Associate Director (A ...

  • Lantheus

    Associate Director of Manufacturing

    6 days ago

    Lantheus North Billerica, United States

    The objective of this position is to provide leadership and management oversight of cold (non-radioactive) product manufacturing technical operations on the Billerica Campus, while ensuring compliance with all GMP, OSHA and other regulatory requirements. The Associate Director (A ...

  • Viridian Therapeutics, Inc

    Associate Director, Device Manufacturing

    1 day ago

    Viridian Therapeutics, Inc Waltham, United States

    : · Reporting to the Vice President, Device Development & Commercialization, the Associate Director, Device Manufacturing will lead technical oversight of process development for assembly, packaging, labelling and functional testing of medical device/drug combination products. Th ...

  • Nanobiosym

    Director of Manufacturing

    3 hours ago

    Nanobiosym Cambridge, United States

    Job Description · Job DescriptionSUMMARY · Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, na ...

  • Nanobiosym

    Director of Manufacturing

    1 week ago

    Nanobiosym Cambridge, United States

    02-May-2024 to 01-Aug-2024 (EST) | Cambridge, MA, USA | Full Time · SUMMARY · Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to wo ...

  • Nanobiosym

    Director of Manufacturing

    1 hour ago

    Nanobiosym Cambridge, United States

    SUMMARY · Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. T ...

  • Commonwealth Fusion Systems

    Manufacturing Director

    6 days ago

    Commonwealth Fusion Systems Devens, United States

    Commonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy.CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fus ...

  • Nanobiosym

    Director of Manufacturing

    6 days ago

    Nanobiosym Cambridge, United States

    SUMMARY Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. This ...

  • Moderna

    Director, INT Manufacturing, DNA

    6 days ago

    Moderna Burlington, United States

    The Role · In this role, you will lead the manufacturing team for the DNA Plasmid manufacturing group at the Moderna site in Burlington, MA, and play a key role on the INT Site Leadership Team. You will also support build of DNA operations at Norwood Moderna Technology Center for ...

  • Landmark Bio

    Director of Manufacturing

    5 days ago

    Landmark Bio Watertown, United States

    You'll lead a dynamic cross-functional team in producing clinical supply products under cGMP conditions. Your responsibilities include ensuring safe, high-quality, and efficient product delivery while fostering employee development and engagement. You'll play a pivotal role in es ...

  • Landmark Bio

    Director of Manufacturing

    6 days ago

    Landmark Bio Watertown, United States

    Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Wa ...

  • Lyra Therapeutics

    Director, Manufacturing Management

    1 week ago

    Lyra Therapeutics Waltham, MA, United States

    Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-21 ...

  • Viridian Therapeutics

    Director, External Manufacturing

    6 days ago

    Viridian Therapeutics Waltham, United States

    At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven ...

  • Deciphera Pharmaceuticals

    Director, Commercial Manufacturing

    1 week ago

    Deciphera Pharmaceuticals Waltham, MA, United States

    Job Description · We are seeking a Chemical Engineer experienced in small molecule Drug Substance and Drug Product process development and commercial manufacturing to join our Pharmaceutical Development and Manufacturing team. This position will support commercial manufacturing ...

  • Deciphera Pharmaceuticals

    Director, Commercial Manufacturing

    5 days ago

    Deciphera Pharmaceuticals Waltham, United States

    Job Description · Job DescriptionCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhib ...

  • Entegris, Inc.

    Director, Direct Procurement

    2 days ago

    Entegris, Inc. Billerica, United States

    _Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that mission._ · **The Role**: · Entegris is seeking a dynamic leader to fill the role of Director, Direct Procurement supportin ...

  • Deciphera Pharmaceuticals

    Director, Commercial Manufacturing

    6 days ago

    Deciphera Pharmaceuticals Waltham, United States

    Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to d ...