Associate Director, MFG (Downstream)

BioSpace; Baltimore (MD); On-site; USD 160,000 - 220,000; Full time

Benefits offered by this job

Competitive salary

Career development opportunities

Job summary

A leading company in pharmaceuticals in Baltimore, MD, is seeking an experienced Associate Director, MFG to lead biologic manufacturing operations. The ideal candidate will have a strong background in cGMP manufacturing, excellent leadership abilities, and experience in biologics drug substance production. Responsibilities include managing operations, ensuring compliance, and driving operational excellence. This role offers a competitive salary and opportunities for professional growth.

Qualifications

• Minimum 8 years experience in biologics drug substance manufacture.
• At least 5 years in a leadership or management role.
• Deep understanding of upstream and downstream unit operations for biologics manufacturing.

Responsibilities

• Lead day-to-day operations in a cGMP biologic manufacturing facility.
• Ensure timely, compliant, and cost-effective manufacture of bulk drug substance.
• Oversee downstream or cell culture manufacturing teams.

Skills

Leadership

Team Management

Operational Excellence

Regulatory Compliance

Problem-solving

Education

Bachelor’s degree in Life Sciences or related field

Tools

cGMP standards

Lean and Six Sigma methodologies

Job description

Join to apply for the Associate Director, MFG (Downstream) role at BioSpace

6 days ago Be among the first 25 applicants

Join to apply for the Associate Director, MFG (Downstream) role at BioSpace

Get AI-powered advice on this job and more exclusive features.

Job Title: Associate Director, MFG

Reporting to: General Manager (Senior Director Manufacturing Operations)

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 Associate General Manager (Associate Director, Manufacturing) is responsible for leading day-to-day operations in a cGMP biologic manufacturing facility, ensuring timely, compliant, and cost-effective manufacture of bulk drug substance. This role will oversee either the downstream or cell culture manufacturing teams, drive operational excellence, and support the execution of strategic initiatives that ensure manufacturing readiness and supply continuity.

You will serve as a key interface between Quality, EHS, Supply Chain, Facilities, Engineering, Validation, MS&T, and CMO Clients to deliver manufacturing performance aligned with corporate and regulatory expectations.

Primary Responsibilities

• Leadership & Team Management
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.
• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.
• Provide day-to-day leadership of manufacturing operations and personnel across shifts.
• Build, develop, and mentor a high-performing, GMP-compliant manufacturing team.
• Set clear expectations and manage performance through coaching, feedback, and development plans.
• Collaborate effectively across functions including MSAT, Quality, Engineering, Supply Chain, and Regulatory.
• Manufacturing Operations
• Oversee cGMP manufacturing of biologics drug substance or drug product (upstream, downstream, or fill-finish).
• Ensure production schedule adherence, right-first-time execution, and minimal batch failures or deviations.
• Monitor and report on KPIs including yield, batch cycle time, deviation rate, and throughput.
• Support 24/7 operations as needed, including off-shift or weekend coverage.
• Quality & Compliance
• Ensure strict adherence to cGMP standards, FDA/EMA regulatory requirements, and internal SOPs.
• Lead and support deviation investigations, root cause analysis, and implementation of effective CAPAs.
• Drive readiness for audits and inspections; represent Manufacturing during regulatory and customer audits.
• Promote and enforce data integrity and robust documentation practices, including completion of batch records and change controls.
• Process Introduction & Technology Transfer
• Lead the transition of new processes into GMP manufacturing, including tech transfer, scale-up, and process validation.
• Serve as the manufacturing lead for new product introductions (NPI), working closely with MSAT and Process Development.
• Ensure facility and equipment readiness, documentation preparation, and personnel training for new processes.
• Lead execution of process performance qualification (PPQ) batches and readiness for commercial launch.
• Continuous Improvement & Operational Excellence
• Identify and lead operational improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Streamline workflows and implement automation or digital tools to enhance efficiency and reduce error rates.
• Evaluate and implement best practices from industry benchmarks and internal performance data.
• Financial & Resource Management
• Support the development and management of manufacturing budgets, labor forecasting, and material usage planning.
• Optimize resource allocation to align with production demands and business objectives.
• The responsibilities listed below represent the core expectations of the role; however, this is not an all-inclusive list. The Associate Director may be assigned additional duties and responsibilities as business needs evolve.
  
  
  

Education & Qualifications

• Bachelor’s degree in chemical engineering, Biochemistry, Biotechnology, Microbiology, Life Sciences, or a related scientific/technical field with minimum 8 years experience in biologics drug substance manufacture.
• At least 5 years in a leadership or management role with proven responsibility for team performance and manufacturing outcomes.
• Experience in clinical and/or commercial manufacturing environments, with understanding of clinical phase progression, facility readiness, and regulatory filings (e.g., IND, BLA, PAI preparation).
• Familiarity with single-use systems, large-scale bioreactors, chromatography systems, UF/DF, and aseptic processing principles.
• Familiar with ICH Q8/Q9/Q10, Annex 1, FDA 21 CFR Parts 210/211, and other global regulatory guidelines
• Strategic thinker with problem-solving agility, decision-making confidence, and a bias for action.
• Experience with new facility startup, equipment commissioning/qualification.
• Deep understanding of upstream (cell culture/fermentation) and/or downstream (harvest/purification) unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.
• Strong leadership presence with the ability to influence across functions and levels of the organization.
• Skilled in managing diverse teams, resolving conflicts, and promoting employee engagement.
  
  
  

Additional Requirements For This Role

In this site-based leadership role, you will be responsible for organizing, coordinating, and directing daily manufacturing operations while providing occasional support during off-hours or on weekends as dictated by production demands (approximately 5% to 10% of the time, with potential for international travel). The position requires the ability to comprehend and follow instructions, independently make quick decisions to solve complex issues, and consistently apply sound judgment in a dynamic environment. Strong analytical skills are essential for interpreting data and information to drive continuous process improvements. You will lead and supervise teams, managing others effectively even when faced with frequent interruptions and shifting priorities.

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.

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Internet News

Referrals increase your chances of interviewing at BioSpace by 2x

Sign in to set job alerts for “Director of Manufacturing” roles.

Baltimore, MD $160,000.00-$220,000.00 2 weeks ago

Hunt Valley, MD $168,900.00-$304,000.00 2 months ago

Sparks, MD $168,900.00-$304,000.00 2 months ago

Senior Director, Commercial Manufacturing Operations

Harmans, MD $280,320.00-$320,000.00 1 week ago

Harmans, MD $190,000.00-$230,000.00 1 week ago

Operations (Director / VP) - Startup Generalist

New York, United States $120,000.00-$170,000.00 1 month ago

Hanover, MD $90,000.00-$120,000.00 2 weeks ago

Manufacturing - Digital Manufacturing, Manager

Operations Director II - Department of Transportation

Baltimore, MD $131,267.00-$216,684.00 2 weeks ago

Columbia, MD $142,327.53-$237,190.02 1 month ago

Columbia, MD $80,000.00-$95,000.00 2 weeks ago

Baltimore, MD $103,040.00-$150,000.00 1 month ago

DIRECTOR OPERATIONS - SURGICAL ONCOLOGY SERVICES

Director, Operations (Provider Engineering)

Operations Director - Environmental/Demolition

Associate Director, Facilities & Metrology

Harmans, MD $150,000.00-$190,000.00 10 hours ago

DIRECTOR OPS - PRIMARY CARE, LBH MEDICAL GROUP

Timonium, MD $150,000.00-$195,000.00 2 weeks ago

Hunt Valley, MD $140,610.00-$253,080.00 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.