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Cmc Biologics Jobs in Bothell, WA (NOW HIRING)

Syner-G

Vice President, Biologics

Seattle, WA · Remote

Lead and personally execute biologics CMC consulting engagements, serving as the primary technical point of contact across program lifecycle * Provide expert guidance across biologics development ...

AGC Biologics

Project Manager

Bothell, WA · On-site

$94K - $129K/yr

Lead CMC development, technology transfer, and GMP manufacturing programs from project initiation ... Apply technical understanding of biologics development and manufacturing to support decision-making ...

SystImmune, Inc

Senior Project Manager

Redmond, WA · On-site

$60K - $85K/yr

Lead cross-functional project planning and execution for oncology biologics programs spanning target/lead discovery, candidate selection, IND-enabling studies, CMC development, and IND submission

Systimmune

Senior Project Manager

Redmond, WA · On-site

$60K - $85K/yr

Lead cross-functional project planning and execution for oncology biologics programs spanning target/lead discovery, candidate selection, IND-enabling studies, CMC development, and IND submission

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All JobsCmc Biologics JobsCmc Biologics Jobs in Bothell, WA

Cmc Biologics information

What is a CMC Biologics?

CMC Biologics refers to the Chemistry, Manufacturing, and Controls (CMC) processes involved in the development and production of biological drugs (biologics). CMC Biologics professionals ensure that biologic products are consistently manufactured to meet quality, safety, and efficacy standards required by regulatory agencies. This involves overseeing the formulation, production processes, quality control, and documentation needed for regulatory submissions and product approvals. They play a crucial role in bringing biologic medicines from early development through to commercial production.

What are common challenges faced by professionals working in CMC Biologics, and how can they be addressed?

Professionals in CMC (Chemistry, Manufacturing, and Controls) Biologics often encounter challenges such as coordinating cross-functional teams, ensuring regulatory compliance, and managing complex timelines for product development. Navigating evolving regulatory requirements and implementing robust quality systems are key aspects of the role. Successful CMC Biologics professionals proactively communicate with stakeholders, stay updated with industry guidelines, and leverage project management tools to ensure alignment across development, manufacturing, and quality teams.

What skills and qualifications are needed to thrive as a CMC Biologics professional?

To thrive as a CMC (Chemistry, Manufacturing, and Controls) Biologics professional, you need a solid background in biochemistry, molecular biology, or chemical engineering, often supported by an advanced degree in a life science field. Familiarity with regulatory guidelines (such as FDA and EMA), quality management systems, and analytical tools like HPLC and mass spectrometry is typically required. Strong problem-solving skills, attention to detail, and effective cross-functional communication set standout professionals apart. These competencies are crucial to ensure regulatory compliance, product quality, and successful biologics development and manufacturing.

What is the difference between Cmc Biologics vs CMC Scientist?

AspectCmc BiologicsCMC Scientist
Required CredentialsBachelor's or Master's in Life Sciences, relevant industry experienceBachelor's or Master's, often with additional certifications in biologics or pharmaceutical sciences
Work EnvironmentBiologics manufacturing facilities, quality control labsResearch labs, development departments, manufacturing support
Employer & Industry UsageBiotech and pharmaceutical companies specializing in biologicsPharmaceutical companies, biotech firms, contract manufacturing organizations

The main difference is that Cmc Biologics typically refers to roles involved in biologics manufacturing and quality assurance, while CMC Scientist focuses on research, development, and process optimization of biologics. Both roles require similar educational backgrounds but differ in daily responsibilities and work settings.

Cmc Biologics jobs near you
Infographic showing various Cmc Biologics job openings in Bothell, WA as of July 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 67% In-person, and 33% Remote job distribution.

Vice President, Biologics

Syner-G

Seattle, WA • Remote

Full-time

Posted 22 days ago

Job description

COMPANY DESCRIPTION:

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Synergbiopharma.com

POSITION OVERVIEW:

Syner-G BioPharma Group is expanding its West Coast presence and is seeking a Vice President, Biologics Development to lead that effort. This is a dual-mandate role: the VP will anchor our biologics delivery capability in the West Coast market and serve as the primary driver of client development and market credibility in that geography.

The West Coast biologics market represents a significant growth opportunity for Syner-G. We have delivery capability but limited local presence, relationships, and brand recognition in that market. This VP hire is the mechanism to change that. The right candidate brings the technical depth to earn trust at the program team level and the commercial instincts to convert that trust into sustained client relationships.

This is a VP-level role with real organizational weight. The hire will report into senior leadership, represent Syner-G in the market, and shape how we show up to the West Coast biotech and biopharma community.

WORK LOCATION:

This position is remote with significant travel to client sites, industry events, and business development activities. Travel may be required up to 75–100%, depending on client and project needs.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or adjusted as needed.)

Market Development and Business Growth

  • Establish and grow Syner-G's presence in the West Coast biologics market, with particular focus on the Bay Area, San Diego, and Seattle biotech corridors
  • Leverage an existing network of biologics sponsor and CRO relationships to open doors, build pipeline, and position Syner-G as a credible biologics CMC partner
  • Collaborate with senior leadership on proposal development, pricing strategy, and scope definition for West Coast opportunities
  • Represent Syner-G at industry events, client meetings, and professional forums in the biologics space
  • Serve as a named resource in client proposals and scope-of-work documents, lending personal credibility to Syner-G's biologics capability narrative

Delivery Leadership

  • Lead and personally execute biologics CMC consulting engagements, serving as the primary technical point of contact across program lifecycle
  • Provide expert guidance across biologics development including upstream and downstream process development, analytical characterization, drug substance and drug product manufacturing, and CMC regulatory strategy
  • Author and provide strategic input on CMC regulatory submissions including INDs, BLAs, and agency meeting packages
  • Partner with Syner-G's broader Pharm Dev and Quality organizations to deliver integrated solutions that draw on the full firm capability
  • Maintain delivery accountability on engagements personally owned, holding the standard for quality and client satisfaction that defines the Syner-G reputation

Internal Contribution

  • Contribute to the build-out of Syner-G's West Coast team over time, including input on talent strategy and hiring for the region
  • Serve as a senior biologics resource across the national delivery organization, sharing expertise and supporting other consultants on complex programs
  • Provide leadership-level perspective on biologics market trends, client segment dynamics, and capability gaps that should inform Syner-G's service evolution

QUALIFICATIONS AND REQUIREMENTS:

Education

  • Advanced degree (Ph.D., M.S., or equivalent) in biochemistry, chemical engineering, pharmaceutical sciences, or a related field.

Experience

  • 20 plus years of biologics CMC experience with substantive time at a major biologics sponsor (Gilead, Amgen, Genzyme, BioMarin, or equivalent large-molecule organization)
  • Deep technical expertise in at least two of the following: upstream process development, downstream purification, analytical development and characterization, drug product formulation, or CMC regulatory affairs for biologics
  • Demonstrated track record of independent technical ownership on IND-enabling through late-stage or commercial biologics programs
  • Prior experience in business development, client relationship ownership, or commercial engagement at a CRO, CDMO, or consulting firm

Preferred Experience

  • Prior consulting or advisory firm experience with demonstrated ability to manage client relationships in a fee-for-service environment
  • Experience managing or mentoring junior technical staff on client engagements

Knowledge, Skills, and Abilities

  • Deep understanding of lyophilization process engineering, freeze-drying technologies, equipment performance, cycle development support, and sterile manufacturing operations.
  • Strong knowledge of aseptic processing requirements, contamination control strategies, Annex 1 guidance, GMP regulations, and pharmaceutical manufacturing best practices.
  • Expertise in commissioning, qualification, startup, performance verification, and operational readiness methodologies.
  • Advanced understanding of automation platforms, SCADA systems, PLCs, control philosophies, alarms, permissives, interlocks, and system integration strategies.
  • Strong technical troubleshooting, risk assessment, and problem-solving capabilities.
  • Exceptional leadership, communication, client relationship management, and business development skills.
  • Ability to establish credibility with executive leadership, technical stakeholders, equipment vendors, and regulatory-facing organizations.
  • Strong project management and organizational skills with the ability to manage multiple high-profile initiatives simultaneously.
  • Ability to mentor teams, drive technical excellence, and support organizational growth.
  • Demonstrated ability to build lasting client relationships and convert technical expertise into long-term business partnerships.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

LEGAL STATEMENT:

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.