Senior Specialist -Engineering

Job description

Job Description The Modality Agnostic Chemistry Scaleup (MACS) Operations team within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. This Senior Specialist position will report to a MACS Facility Lead (Associate Director, Engineering) as a part of the core engineering team supporting the MACS facility. The incumbent will hold a process engineering role, serving as both an individual contributor and a technical mentor to support the MACS facility – a new, potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing pilot plant currently under construction in Rahway, New Jersey. The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP). As the MACS facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup and subsequent batch processing. The selected candidate is expected to be a key part of a team of process/facility engineers and foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of the Company’s pipeline. This role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities. Key responsibilities of this role include: Leverage depth and breadth of scientific, technical, and operational experience to support facility start up and long-term operations. Author and review documentation required for facility start up, non-GMP and GMP operations. Cleaning and Containment Verification (CCV) for the suite of specialized equipment for MACS potent processing – includes managing the CCV strategy, providing shop floor support for testing, and working with key partners in Analytical, Quality, and Safety for testing. Industrial Hygiene strategy and controls – includes working with Safety & Environmental partners. Provide mentorship and oversight for the extended team to progress facility needs. Additional Supported Areas As required and in addition to support of current capital projects the Senior Specialist may provide direct support to other areas of Rahway such as: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Prep Lab Area: The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as Antibody Drug Conjugates (ADCs), Peptide Drug Conjugates (PDCs), and other cross modality compounds that require a more flexible potent compound processing space. Education Minimum Requirement: Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 5 years relevant experience, or a Master’s degree with 4 years of relevant experience, or a PhD degree with 1 years of relevant experience. Required Experience and Skills: Experience in GMP clinical supply facility. Experience with GMP facility design, equipment start-up and/or qualification. Experience with small molecule drug substance and/or biologics process development. Experience in supporting compliance investigations and change management. Familiarity with US and EU GMP and Safety compliance regulations Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA) Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture. Ability to prepare Standard Operating Procedures (SOP) and cGMP documents. Effective interpersonal and communication skills, both verbal and written. Excellent organizational skills to multi-task. Desire and willingness to learn, contribute and lead. Track-record of independent problem-solving. Desired Experience and Skills: Experience operating/maintaining pilot scale or prep lab scale equipment. Experience providing technical mentorship. Experience with Potent Compound processing and containment systems (e.g., isolators). Experience performing and/or overseeing quantitative industrial hygiene (IH) exposure evaluations. Experience with Quality systems Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc. Experience working in an environment with an Automation System (DeltaV, PLC, etc.). Experience with coordinating maintenance activities around processing activities to support reliable facility operation. Required Skills: Adaptability, Adaptability, Analytical Testing, Antibody Drug Conjugates (ADC), Capital Projects, Change Management, Chemical Engineering, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Hazard Analysis, Industrial Hygiene, Pharmaceutical Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Production Process Development, Research and Development, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come