Manufacturing Bioprocess Associate (Downstream)

Initial Therapeutics, Inc.; Baltimore (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

Syngene International Ltd. is seeking a Manufacturing Bioprocess Associate (Downstream) to perform complex biologics manufacturing activities with minimal supervision.

The role supports downstream operations including chromatography and TFF, and requires strong GMP documentation and cleanroom practices. The candidate will work on process equipment operation, media preparation, system setup, and sterilization support, contributing to cGMP batch records and continuous improvement initiatives.

Qualifications

• Associate or Bachelor degree in a science-related field is required.
• 2–4 years of biologics manufacturing experience (upstream or downstream).
• Working knowledge of GMP documentation, cleanroom behaviour, and aseptic techniques.
• Experience with new facility startup, equipment commissioning/qualification.
• Deep understanding of upstream and downstream unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.

Responsibilities

• Execute upstream or downstream unit operations per batch requirements.
• Prepare and test media/buffer solutions, including pH/conductivity adjustments.
• Operate and maintain sterilization systems and perform cleaning, sanitization, and line clearance.
• Document Master Batch Records under cGMP using SOPs and batch records.
• Support 24/7 operations and assist in process transfers and tech transfer activities.

Skills

GMP documentation

Aseptic techniques

Cleanroom behaviour

Safety-consciousness

Education

Associate or Bachelor degree in a science-related field

Tools

Equipment commissioning/qualification

Job description

Job Title: Manufacturing Bioprocess Associate (Downstream)

Reporting to: Supervisor, Manufacturing

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Job Summary

The Senior Executive (Senior Manufacturing Associate) performs complex biologics manufacturing activities with minimal supervision. This role supports upstream or downstream operations including buffer/media preparation, process equipment operation, system setup, and sterilization support.

Primary Responsibilities

• 1. Manufacturing Operations
• Execute upstream (seed train, bioreactor) or downstream (chromatography, TFF) unit operations in accordance with batch requirements.
• Prepare and test media or buffer solutions following SOPs and batch instructions, including pH and conductivity adjustments.
• Operate and maintain glass wash and autoclave systems to ensure proper sterilization and availability of process components.
• Assist in system setup, tubing configurations, and filter integrity testing.
• Perform cleaning, sanitization, and line clearance of equipment and cleanroom areas.
• Execute Master Batch Records (MBR) under cGMP and document all operations clearly using SOPs and batch records.

• 3. Quality/Compliance
• Execute Master Batch Records (MBR) under cGMP, and document in detail through the use of SOPs and MBRs for the processes and manufacturing steps.
• Ensure strict adherence to cGMP standards, FDA/EMA regulatory requirements, and internal SOPs.
• Support deviation investigations, root cause analysis, and implementation of effective CAPAs.
• Adhere to data integrity and robust documentation practices, including completion of batch records and change controls.
• Ensure cGMP compliance of batch records, logbooks, and cleaning documentation.
• Contribute to deviation investigations, CAPA development, and quality documentation.

• Support 24/7 operations as needed, including off-shift or weekend coverage.
• All other duties as assigned

• 4. Process Introduction & Technology Transfer
• Serve as the manufacturing support for new product introductions (NPI), working closely with MSAT and Process Development.
• Ensure facility and equipment readiness, documentation preparations (SOPs and Master Batch Records, and personnel training for new processes.
• Support execution of process performance qualification (PPQ) batches and readiness for commercial launch.

• 5. Continuous Improvement & Operational Excellence
• 5S standards are maintained
• Propose and implement process improvements.

The responsibilities listed below represent the core expectations of the role; however, this is not an all-inclusive list. The Senior Executive may be assigned additional duties and responsibilities as business needs evolve.

Education & Qualifications

• Associate or Bachelor degree in a science related field or equivalent relevant experience required.
• 2–4 years of biologics manufacturing experience (upstream or downstream).
• Working knowledge of GMP documentation, cleanroom behaviour, and aseptic techniques.
• Experience with new facility startup, equipment commissioning/qualification.
• Deep understanding of upstream (cell culture/fermentation) and Downstream (purification) unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.

Additional requirements for this role

• In this site-based role your work schedule may be fluid to support a 24/7 manufacturing operation, including weekends, nights, and holidays. Schedule changes may occur based on business needs.
• During Routine production, the manufacturing supervisor is expected to be on the manufacturing floor at least %75 of the time.
• The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The role demands good eye/hand coordination, visual acuity, and proficiency in using keyboards, computers, and phones. Sensory awareness—including the ability to detect and distinguish smells and sounds—is important for safety and quality assurance. Physical competencies such as maintaining a stationary position, moving or traversing the facility, ascending or descending (climbing), reaching, and safely operating hand tools and performing repetitive movements are integral, as is the ability to move or transport required loads.

A commitment to regular and predictable attendance is necessary, as is the flexibility to work irregular hours that often include nights and weekends. The position involves working in environments with extreme temperatures, high noise levels, restricted laboratory access, and exposure to dust, gas, fumes, steam, or chemicals. This multifaceted role supports the organization’s operational continuity and ensures safety and efficiency across all aspects of manufacturing leadership. The role may require approximately 5% to 10% of travel and may include international travel basis business needs.

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.