A-BIO is seeking a Process Specialist to join our team in Maryland. At A-BIO, we differentiate ourselves through owner-side experience and in-depth process / operational knowledge. Our Process Specialists are industry experts in bioprocessing and are pivotal in spearheading strategies for complex technical projects in the biopharma sector, working at the forefront of the industry to drive innovation and excellence.
Position Overview
As a Process Specialist at A-BIO, you will use your deep understanding of biopharmaceutical manufacturing processes and operations across various scales and modalities. This role requires applying technical expertise and operational insights to formulate project strategies, oversee execution plans, and deliver technical outcomes across diverse modalities, including mammalian, microbial, mRNA, gene and cell therapy.
Key Responsibilities
Technical Leadership and Execution:
- Develop and direct technical project strategies and visions focused on the manufacture of biopharmaceutical products
- Manage engineering teams during all project phases
- Capacity, expansion, and operational readiness strategies
- Support technology transfer strategy and execution
- Develop technical documentation, such as SOPs, risk assessments, process flow diagrams, and protocols
- Support capital project management strategies, specifically focused on technical execution elements like design, CQV, and operational readiness
- Develop process control strategies and narratives to translate design intent to automation integrators
- Lead process automation strategy development and implementation, including overseeing automation integration contractors
- Lead process data collection and process modeling development
- Support the development of commissioning, qualification, and validation strategies and work processes
- Participate in CQV execution including FAT/SAT, commissioning, and start-up activities
- Establish and maintain standards for engineering documentation, ensuring quality and compliance
- Coordinate with cross-functional teams that include Validation, Manufacturing, Quality, Supply Chain, and Engineering
- Build and maintain strong relationships with internal teams, clients, and external vendors
- Facilitate project meetings, ensuring effective communication and timely execution of tasks
- Prioritize and help drive project initiatives, ensuring high-quality, timely completion of team deliverables
- Enhance decision-making through effective communication, fostering collaboration and consensus
- Serve as a Subject Matter Expert in specific technical areas, providing mentoring and training to A-BIO staff
- Develop capabilities in capital project management, facility builds, validation lifecycles, quality/regulatory compliance, and client management
- Develop baseline knowledge and capabilities in project management
- Engage in ongoing learning within the life sciences to remain at the cutting edge of theindustry
Minimum Qualifications
- Minimum 10 years of experience within a cGMP-regulated industry
- Bachelor’s degree or higher in Engineering or Life Sciences
- Understanding of standard processes for mAbs, gene therapy, and/or cell therapy
- Subject Matter Expertise in at least one biopharma manufacturing modality
- Expertise in pharmaceutical process equipment, including design through operations
- Familiarity with process automation
- Comprehensive knowledge of cGMP regulations, ASME BPE, and ISPE guidelines
- GMP change control experience
- Proficiency in handling deviations, nonconformances, batch record systems, and SOP development
- Excellent communication skills, both verbal and written
- Proven ability to manage time effectively and prioritize tasks
Beneficial Qualifications
- Subject Matter Expertise in at least two biopharma manufacturing modalities
- 5+ years of owner’s side operations experience
- Experience in GMP manufacturing facility design and operation
- Experience with design, start-up, shutdowns, return to service, and troubleshooting of manufacturing systems and facilities
- Project management skillset
