Project Manager - Biotech - LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

We are seeking a dynamic and experienced R&D Project Manager to lead and oversee multiple new product development projects within the pharmaceutical, biotechnology and AgBio sectors. The ideal candidate, will be responsible for planning, executing, and finalizing projects, to a high-quality driven standard and according to strict deadlines and within budget. They will interact closely with R&D, quality, commercial, and manufacturing team members to ensure the successful completion of the design control process for new products. This role requires a strategic thinker with strong leadership skills, technical expertise, and the ability to manage cross-functional and multi-geographical teams.

• Project Planning and Management:
  • Define project scope, goals, and deliverables in collaboration with senior management and stakeholders.
  • Develop comprehensive project plans, including timelines, resource allocation, and budget management in partnership with the R&D, Commercial, Ops, Manufacturing, QA/RA.
  • Support and implement New Product Design and Development Plans in accordance with the design control requirements of: 21 CFR 820, ISO 13485, and all applicable design control procedures.
  • Monitor and track project progress, ensuring timely and within-budget delivery.
  • Identify potential risks and implement mitigation strategies.
• Team Leadership:
  • Lead and manage cross-functional project teams, fostering a collaborative and high-performance culture.
  • Assign tasks and responsibilities to team members and provide guidance and support.
  • Facilitate communication and collaboration among team members and stakeholders.
• Technical Oversight:
  • Oversee the technical aspects of projects, ensuring adherence to industry standards and best practices.
  • Evaluate and integrate new technologies and methodologies to enhance project outcomes.
  • Conduct regular project reviews and provide technical input to address challenges and optimize solutions.
• Stakeholder Management:
  • Act as the primary point of contact for all project-related communications with stakeholders.
  • Prepare and deliver project reports, presentations, and documentation to stakeholders and senior management.
  • Ensure stakeholder expectations are managed and met throughout the project lifecycle.
• Quality Assurance:
  • Implement and maintain quality control processes to ensure the highest standards of project deliverables.
  • Conduct post-project evaluations to identify areas for improvement and best practices.

• Bachelor’s degree in an Engineering or Scientific discipline is required.
• 2-3 years’ experience in project management and new product development, ideally within the pharmaceutical, biotechnology, or AgBio sectors is required. 
•  3-5 years proven experience working within large, global, multi-discipline R&D or product development projects that include both business and technical resources within the pharmaceutical, life sciences, or diagnostics arena.
• Strong understanding of R&D processes, methodologies, and technologies.
• Product development experience and knowledge of product development frameworks and procedures, specifically systems-level experience designing and supporting multiple disciplines in a scientific field.
• Demonstrable knowledge of Quality Management Systems and experience ensuring compliance to ISO and Regulatory requirements.
• Experience with medical devices FDA QSR and ISO13485, reagent manufacturing, international project management skills, validation/qualification process, and knowledge management.
• A recognized project management qualification (e.g., PRINCE, PMI PMP) is strongly preferred.

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options
• Great onsite gym!
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more!

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website www.lgcgroup.com

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