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Manufacturing Science and Technology Specialist

2 months ago

Princeton, New Jersey, United States LanceSoft Full time
Work Schedule: Mon-Fri 8am to 5pm

Essential Experience: Expertise in Gene/Cell Therapy Manufacturing

Position Overview:
  • The Manufacturing Science and Technology (MS&T) Specialist offers essential technical assistance to our operations.
  • Engagement in manufacturing processes within a Good Manufacturing Practice (GMP) environment.
  • Technical assistance encompasses diagnosing process and equipment-related challenges that arise during production.
  • The MS&T Specialist collaborates closely with Manufacturing and Quality teams to ascertain immediate corrective measures for deviations, identify root causes, and implement enduring preventive strategies.
  • Additional duties include participating in process technology transfers and incoming process modifications, communicating these changes to relevant departments, and spearheading process enhancement initiatives at the facility.
  • The MS&T Specialist actively seeks and drives continuous enhancements to the manufacturing workflow.
  • Acts as a subject matter expert in technology and processes.
  • Provides on-site technical support to manufacturing operations as required.
  • Responsible for authoring, reviewing, and approving various documents (e.g., Batch Records, Standard Operating Procedures).
  • Creates and approves protocols and reports in alignment with internal and external regulatory standards.
  • Analyzes and summarizes manufacturing data to facilitate impact assessments and investigations.
  • Oversees change controls related to process and procedural modifications.
  • Leads and executes investigations within the Corrective and Preventive Action (CAPA) system.
  • Guides technology transfer efforts for new processes and product implementations.
  • Conducts facility fitness assessments, gap analyses, and risk evaluations when onboarding new programs.
  • Utilizes continuous improvement methodologies to identify and rectify procedural and compliance deficiencies.
  • Identifies opportunities for process enhancements and operational efficiencies, leading implementation efforts.
  • Represents MSAT and collaborates with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
  • Supports equipment and systems validation activities, including reviewing equipment qualification documents, drafting user requirement specifications, and participating in impact assessments.
  • Must be capable of performing gowning procedures and entering the manufacturing area.
  • Some travel may be necessary.
Educational and Experience Requirements:
  • Bachelor's degree and/or advanced degree in Science or Chemical/Biological Engineering.
  • A minimum of 5 years of industry experience.
  • At least 3 years of relevant experience in GMP biologics/cell therapy manufacturing technical or process support.
  • Advanced degrees are preferred.
Knowledge and Skills Requirements:
  • Strong scientific foundation in bioprocessing principles, with a preference for familiarity with cell therapy processes and cGMP.
  • Experience in process qualification and validation.
  • Experience with the startup, validation, and licensure of new biopharmaceutical manufacturing facilities is highly advantageous.
  • Familiarity with program management software and tools is a plus.
  • Experience working with external stakeholders and cross-functional teams.
  • Experience interfacing with clients.
  • Strong verbal and written communication skills with the ability to influence at all organizational levels.
  • Strategic thinking capability with the ability to translate strategy into actionable steps.
  • Ability to prioritize tasks in a fast-paced environment.
Employee Benefits:
At LanceSoft, full-time regular employees who work a minimum of 30 hours per week are eligible for the following benefits:
  • Four options for Medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Additional Employee Perks
About LanceSoft:
LanceSoft is recognized as one of the largest staffing firms in the United States. Our mission is to foster global cross-cultural human connections that advance the careers of our employees and enhance the businesses of our clients. We leverage our extensive global network to connect businesses with the right talent and individuals with the right opportunities, ensuring a bias-free approach. We provide Global Workforce Solutions with a personal touch.

EEO Employer:
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We strictly prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as defined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.