Senior Manufacturing Bioprocess Associate (Downstream)

Job Title: Senior Manufacturing Bioprocess Associate (Downstream)

Job Location: Baltimore USA

Reports To : Supervisor Manufacturing

Department : Manufacturing

About Syngene: Syngene () is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

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.

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and respective teams.
• Contributing to the development of procedures practices and systems that ensure safe operations and compliance with the companys integrity & quality standards.
• Driving a corporate culture that promotes environment health and safety (EHS) mindset and operational discipline at the workplace.
• Ensuring safety of self teams and lab/plant by adhering to safety protocols and following environment health and safety (EHS) requirements always in the workplace.
• Ensure all assigned mandatory training related to data integrityhealth and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards.

Core Purpose of the Role:

The Senior Manufacturing Bioprocess Associate (Downstream) 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.

Role Accountabilities

• 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 Manufacturing Bioprocess Associate may be assigned additional duties and responsibilities as business needs evolve.

Syngene Values

All employees will consistently demonstrate alignment with our core values.

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

• Associate or Bachelor degree in a science related field or equivalent relevant experience required.
• Independently performs standard tasks 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.
• Experience with Industry Applications such UNICORN SAP TrackWise Delta V is preferred.

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 Senior Manufacturing Bioprocess Associate 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 awarenessincluding the ability to detect and distinguish smells and soundsis 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 organizations 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 color 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 addition Syngene will provide reasonable accommodation for qualified individuals with disabilities.