Biomanufacturing Associate II Upstream

This Senior Manufacturing Associate II Upstream role plays a critical part in gene therapy manufacturing by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles to designated production processes in a regulated environment. The position independently executes start-to-finish floor-level activities, some of which are complex, to ensure the timely production and release of high-quality products that meet client specifications. The role requires strong technical expertise, consistent adherence to cGMP and quality standards, and the ability to mentor others while driving continuous improvement across upstream, downstream, and fill-finish operations.

Responsibilities

• Apply and adhere to standard operating procedures (SOPs), current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), quality standards, and safety requirements at all times.
• Independently execute floor-level manufacturing tasks in accordance with SOPs in one or more areas, including downstream activities and fill-finish activities.
• Assist in coordinating and executing floor activities in alignment with the batch production record to ensure accurate and timely completion of manufacturing operations.
• Apply advanced Good Documentation Practices (GDP) when preparing, editing, reviewing, and implementing quality documents to maintain compliance and data integrity.
• Perform daily batch production record (BPR) reviews to ensure completeness, accuracy, and compliance with regulatory and internal standards.
• Participate in and co-lead cGMP audits and investigations, contributing technical insight and supporting corrective and preventive actions.
• Ensure high data integrity by accurately documenting, analyzing, and reviewing all work performed in the manufacturing environment.
• Prepare, clean, maintain, inspect, and operate manufacturing equipment, and assist with equipment calibrations to support reliable and consistent operations.
• Troubleshoot routine to moderately complex manufacturing issues using root cause analysis and implement appropriate corrective actions.
• Co-lead health and safety prevention initiatives aimed at reducing risk and promoting a strong safety culture in the manufacturing environment.
• Comply with safety regulations and site-based guidelines by consistently applying cleanroom and aseptic behaviors and procedures.
• Follow personal protective equipment (PPE) and gowning requirements, including proper preparation, disinfection, sterilization, and sanitation methods for equipment and materials.
• Safely handle, transport, store, and dispose of biological specimens, chemicals, and hazardous materials in accordance with biosafety and regulatory requirements.
• Apply an understanding of biosafety levels and implement specific controls and universal precautions, including OSHA guidelines, as appropriate.
• Assist in training others to avoid accidents and unsafe situations, reinforcing best practices in safety and compliance.
• Mentor and train colleagues by sharing knowledge, experience, and best practices to build a capable and confident manufacturing team.
• Provide recommendations and implement continuous improvement and LEAN manufacturing solutions to create efficiencies and enhance processes.
• Ensure 100% on-time completion of personal and assigned training plans and maintain training records up to date.
• Demonstrate punctuality and flexibility with work schedules and tasks to support changing business demands and production needs.
• Collaborate effectively with cross-functional teams, maintaining a professional tone and demeanor while supporting an operations and customer-focused mindset.
• Perform other related responsibilities as assigned to support gene and cell therapy manufacturing operations and overall business objectives.

• High school diploma or equivalent and 6 years of related experience, or an associate degree with 5 years of related experience, or a bachelor’s degree in biology, life sciences, bioengineering, or a related discipline with 3 years of related experience.
• Prior cell or gene therapy experience in a highly technical role covering a wide range of tasks within a cGMP biotech manufacturing environment or related industry.
• Demonstrated ability to independently execute manufacturing protocols and floor-level tasks from start to finish within a regulated environment.
• Strong knowledge and practical application of cGMP, GLP, and Good Documentation Practices (GDP).
• Proficiency in cleanroom operations, aseptic techniques, and gowning requirements, including the ability to pass and maintain aseptic and gowning qualifications.
• Experience with downstream activities and fill-finish operations in a biopharmaceutical or gene therapy manufacturing setting.
• Ability to conduct daily batch production record reviews and maintain high standards of documentation accuracy and completeness.
• Experience participating in or co-leading GMP audits and investigations, including supporting root cause analysis and corrective actions.
• Strong attention to detail with excellent documentation and data integrity skills.
• Advanced analytical, critical thinking, and problem-solving skills applied to manufacturing issues and process improvements.
• Ability to plan, coordinate, and execute multiple projects simultaneously and deliver results on time.
• Strong listening skills and clear written and verbal communication abilities for effective collaboration and documentation.
• Working knowledge and application of MS Word, Excel, PowerPoint, Teams, and relevant databases.
• Ability to work in a cleanroom environment for at least 4 hours per day and comply with all associated requirements.

• Informal coaching or project management experience is desirable, particularly in a manufacturing or technical environment.
• Qualification as a LEAN trainer or willingness to become qualified to support continuous improvement initiatives.
• Experience providing recommendations and implementing LEAN and continuous improvement solutions in a manufacturing setting.
• Ability to foster collaboration as a team player with a positive attitude, professional tone, and demeanor.
• Capability to engage, inspire, assist, and mentor others to support team development and knowledge sharing.
• Demonstrated operations and customer-focused mindset, with a commitment to delivering high-quality products and services.
• Willingness to continuously learn and improve, staying current with evolving manufacturing practices and technologies.
• Pride in delivering high-quality work on time with minimal need for rework.
• Comfort working within structured values-based environments that emphasize integrity, quality, and teamwork.

The role is based in a GMP manufacturing suite and cleanroom environment dedicated to cell and gene therapy production. You will work in a regulated setting that requires consistent adherence to cGMP, GLP, and strict quality and safety standards. The position involves working in a cleanroom for at least 4 hours per day, following aseptic techniques, gowning procedures, and the use of appropriate personal protective equipment. You will regularly handle and operate specialized manufacturing equipment, as well as manage biological specimens, chemicals, and hazardous materials in accordance with biosafety levels and universal precautions. The environment emphasizes punctuality, flexibility in work schedules and tasks, and collaboration within cross-functional teams. Daily work involves the use of digital tools such as MS Word, Excel, PowerPoint, Teams, and databases for documentation and communication. The culture supports continuous improvement, LEAN practices, mentoring, and a strong focus on safety, data integrity, and high-quality output.

Job Type & Location

This is a Contract position based out of Rockville, MD.

The pay range for this position is $27.42 - $28.68/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Rockville,MD.

This position is anticipated to close on Jun 24, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.