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Cmc Project Manager Jobs in Silver Spring, MD (NOW HIRING)

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · Hybrid

$162K - $213K/yr

... CMC, Labeling, and members of the submission and execution team in formulating global regulatory ... senior management on project risks/mitigation activities. Ensure appropriate planning and ...

IQVIA

Director, Regulatory Affairs

Washington, DC

$169K - $224K/yr

The Director will also manage various personnel during various projects, as well as act as a mentor ... Bachelor's degree in a scientific, engineering, or regulatory discipline (e.g., CMC); MS or PhD ...

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Cmc Project Manager information

See Silver Spring, MD salary details

$46.5K

$108.6K

$175.2K

How much do cmc project manager jobs pay per year?

As of Jun 11, 2026, the average yearly pay for cmc project manager in Silver Spring, MD is $108,573.00, according to ZipRecruiter salary data. Most workers in this role earn between $85,800.00 and $132,800.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Cmc Project Manager position, and why are they important?

A CMC Project Manager needs strong expertise in Chemistry, Manufacturing, and Controls (CMC) processes, project management certifications (such as PMP), and a background in pharmaceutical or biotech industries. Familiarity with regulatory submission systems, quality management software, and documentation tools is highly valued. Exceptional organizational skills, problem-solving ability, and effective cross-functional communication help candidates excel in this role. These capabilities are critical for ensuring project milestones are met, regulatory requirements are satisfied, and product development remains on track.

What are some typical responsibilities of a CMC Project Manager in a pharmaceutical company?

A CMC Project Manager is responsible for coordinating cross-functional teams to ensure successful delivery of project milestones related to product development, manufacturing, and regulatory submissions. Their daily tasks often include developing project timelines, managing risk assessments, overseeing documentation, and facilitating communication between technical, regulatory, and quality departments. They play a pivotal role in preparing CMC sections for regulatory filings, supporting process optimization, and troubleshooting manufacturing challenges. This position requires excellent multitasking abilities and close collaboration with internal stakeholders and external partners throughout the product lifecycle.

What are the 7 keys of project management?

The 7 keys of project management typically include scope, time, cost, quality, communication, risk, and stakeholder management. A CMC Project Manager must effectively plan, execute, and monitor these areas to ensure project success, often utilizing tools like Gantt charts and project management software. Mastery of these keys helps in delivering projects on time, within budget, and to the desired quality standards.

What is a CMC project manager?

A CMC project manager oversees Chemistry, Manufacturing, and Controls activities in pharmaceutical or biotech development, ensuring compliance with regulatory standards and timely project delivery. They coordinate cross-functional teams, manage budgets, and utilize project management tools to meet development milestones.

Is PMO better than project manager?

A Project Management Office (PMO) is a department that standardizes project management practices across an organization, while a project manager is an individual responsible for planning and executing specific projects. The PMO provides governance, tools, and support, whereas the project manager focuses on delivering project outcomes; both roles are essential but serve different functions. The effectiveness depends on organizational structure and project complexity.

What is a CMC Project Manager job?

A CMC (Chemistry, Manufacturing, and Controls) Project Manager oversees the development, manufacturing, and regulatory aspects of pharmaceutical products. They coordinate cross-functional teams, manage timelines, and ensure compliance with regulatory requirements. Their role is critical in guiding drug development from early stages to commercialization while maintaining quality and efficiency.

What is the highest paying project manager job?

The highest paying project management roles are often in industries like oil and gas, aerospace, and IT, with senior or executive-level positions such as Program Manager, Portfolio Manager, or Director of Project Management typically earning the highest salaries. Certifications like PMP or PgMP and extensive experience can also contribute to higher compensation. Salaries vary by industry, location, and company size but can exceed $150,000 annually for top-tier roles.
What job categories do people searching Cmc Project Manager jobs in Silver Spring, MD look for? The top searched job categories for Cmc Project Manager jobs in Silver Spring, MD are:
What cities near Silver Spring, MD are hiring for Cmc Project Manager jobs? Cities near Silver Spring, MD with the most Cmc Project Manager job openings:
Cmc Project Manager jobs near you
Infographic showing various Cmc Project Manager job openings in Silver Spring, MD as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $108,573 per year, or $52.2 per hour.
Associate Principal Scientist, Viral Vector Downstream Process Development

Associate Principal Scientist, Viral Vector Downstream Process Development

AstraZeneca

Gaithersburg, MD • On-site

Other

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago

AstraZeneca rating

8.6

Company rating: 8.6 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

16th of 71 rated pharmaceutical

Job description

AstraZeneca is seeking a highly motivated and experienced Associate Principal Scientist in Viral Vector Downstream Process Development to support and expand our growing Cell Therapy and Gene Therapy portfolio. This role will play a critical leadership position in establishing robust, scalable, and phaseappropriate lentiviral vector (LVV) downstream purification processes from early development through clinical and commercial readiness. The successful candidate will lead matrixed project teams, act as a technical authority for LVV downstream purification, and partner closely with crossfunctional stakeholders including Research, Upstream PD, Analytical Development, CMC, Manufacturing, Quality, Regulatory, and external CDMOs.

Key Responsibilities Downstream Process Development & Strategy Define, develop, and execute endtoend LVV downstream purification strategies for ex vivo and in vivo applications with focus on yield, purity, potency, consistency, scalability, and cost. Establish platformaligned, phaseappropriate purification processes suitable for INDenabling, clinical, and commercial manufacturing. Provide scientific leadership and technical oversight across clarification, chromatography, UF/DF (TFF), and sterile filtration operations.

Matrix Leadership & Project Execution Lead and influence crossfunctional, matrixed project teams, driving alignment on technical strategy, timelines, and decisionmaking. Coach and guide scientists and engineers for the execution of downstream development activities. Ensure highquality experimental design, execution, data interpretation, and timely communication of results.

ScaleDown Models, ScaleUp & Technology Transfer Design and qualify representative scaledown models to support process characterization and comparability. Support scaleup to pilot, clinical, and commercialrelevant equipment and consumables. Author, review, and approve technology transfer packages, and support successful implementation at internal GMP sites and external CDMOs.

CMC & Regulatory Enablement Contribute to and shape CMC downstream development strategies, including control strategy, inprocess monitoring, and operating ranges. Author and review CMCrelevant documentation (development reports, batch records, process descriptions). Support preparation of regulatory submissions (e.g., IND)

Process Characterization, QbD & Risk Management Lead process characterization and platform studies, including DOEbased investigations. Apply QbD principles, risk assessments (e.g., FMEA), and scientific justification to define design space and control strategy. Drive root cause investigations, troubleshooting, and continuous improvement initiatives

Innovation & Continuous Improvement Identify and evaluate novel and nextgeneration purification technologies (e.g., advanced chromatography, membranes, PAT/digital tools). Champion platform evolution, efficiency gains, and robustness improvements aligned with longterm modality strategy. Documentation, Compliance & Quality Ensure development activities adhere to cGMP concepts, data integrity, and Quality Systems expectations

Author and review protocols, reports, development summaries, and technical documents at a high standard of scientific and regulatory quality. Interface closely with Quality to ensure inspection readiness and compliance. Qualifications Education M.S

with 10+ years, or Ph.D. with 7+ years of handson industry experience in downstream process development. Technical & Industry Experience Extensive, handson experience in LVV downstream process development (strongly preferred) or other viral vectors/biologics

Deep expertise in clarification, chromatography, UF/DF (TFF), and sterile filtration. Strong understanding of viral vectorspecific impurity profiles (HCP, host cell DNA, process residuals) and mitigation strategies. Experience supporting clinical and/or commercial scale processes, including tech transfer.

CMC, GMP & Regulatory Proven working knowledge of cGMP principles, Quality Systems, and relevant FDA/EMA guidance for gene and cell therapies. Direct experience contributing to CMC sections of regulatory filings. Data, Statistics & Risk Tools Advanced experience with statistical analysis, DOE, and multivariate data interpretation.

Strong application of QbD, risk management, and process justification methodologies. Leadership & Collaboration Excellent written and verbal communication skills. Demonstrated ability to lead in matrixed environments, influence stakeholders, and resolve complex technical challenges.

Preferred Qualifications Track record of scaling LVV or viral vector purification processes from preclinical through clinical and commercialrelevant equipment. Experience supporting technology transfer to GMP manufacturing sites and CDMOs. Exposure to PAT, digital tools, and data/knowledge management systems.

Demonstrated success in building and delivering nextgeneration purification processes endtoend. The annual base pay for this position ranges from $142,377.60 - $213,566.40. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 03-Jun-2026 Closing Date 04-Jun-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.

If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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