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Quality Control Analytical Development Manager Jobs

WuXi AppTec

QC Raw Material Scientist

Middletown, DE · On-site

The QC Raw Material Scientist will support material disposition, supplier qualification ... analytical methods used for raw material testing. * Support qualification and lifecycle management ...

Samprasoft

Quality Control Analyst

Washington, DC · On-site

$27.25 - $36.50/hr

Master's degree in a related discipline If you are an experienced Senior Quality Control Analyst with a deep understanding of system development lifecycle management, business audit process, and ...

Samprasoft

Quality Control Analyst

Washington, DC · On-site

$27.25 - $36.50/hr

Master's degree in a related discipline If you are an experienced Senior Quality Control Analyst with a deep understanding of system development lifecycle management, business audit process, and ...

Intellia Therapeutics

Director, QA for QC

Cambridge, MA · On-site

The Director, QA for QC is responsible for providing strategic and operational quality oversight of ... management. * Partner with Analytical Development, Process Development, and Manufacturing Sciences ...

Piramal Pharma Limited

QC Analyst I

Sellersville, PA · On-site

$23.25 - $31.25/hr

Enter, review, and submit raw data and analytical results in the Laboratory Information Management ... Support training and development activities as assigned. * Perform other duties as assigned by ...

Kent Corporation

QUALITY CONTROL ANALYST

Washington, IN · On-site

$20.50 - $27.75/hr

Work on special projects related to method/instrument development and validation as directed by the ... Maintain good communication with all Analytical Services co-workers, Analytical Services Management ...

Adecco

Quality Control I

Piscataway, NJ · On-site

$23 - $26.30/hr

Perform quantitative analytical testing while maintaining a high level of accuracy and attention to ... Comfortable working in a fast-paced environment and managing multiple priorities. * Proficiency ...

Ubertal Inc

Quality Control Analyst

Holly Springs, NC · On-site

$20.75 - $28/hr

Quality Control Analyst Location: Holly Springs, Wake County, North Carolina Job Type: Contract ... Knowledge of analytical methods and related laboratory instrumentation. * Experience with GLIMS ...

Regeneron Pharmaceuticals, Inc

NY · On-site

$92K - $150K/yr

This role requires Must‑haves: * 8+ years of industry experience in analytical development, laboratory automation, and QC method lifecycle management (or equivalent combination of education and ...

LegendBiotech

WI · On-site

$23.25 - $31.25/hr

... analytical testing from the test bench to production. * Documentation and data management:You will ... We value and encourage learning and personal development. * The opportunity towork with people from ...

BERJE INCORPORATED

QC Analyst

Carteret, NJ

$26 - $31/hr

The ideal candidate is detail-oriented, analytical, and collaborative, with the ability to manage ... method development, and investigative analysis. * Operate, monitor, and maintain laboratory ...

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How much do quality control analytical development manager jobs pay per year?

As of Sep 9, 2026, the average yearly pay for quality control analytical development manager in the United States is $81,324.00, according to ZipRecruiter salary data. Most workers in this role earn between $60,500.00 and $100,000.00 per year, depending on experience, location, and employer.

What does a quality control analytical development manager do?

A Quality Control Analytical Development Manager oversees the development, validation, and implementation of analytical methods to ensure the quality and safety of products, often within the pharmaceutical, biotechnology, or manufacturing industries. They lead teams responsible for testing raw materials, intermediates, and finished products, ensuring compliance with regulatory standards and industry best practices. The role also involves troubleshooting analytical issues, optimizing laboratory processes, and collaborating with other departments such as R&D and manufacturing. This position is critical for maintaining product integrity and supporting regulatory submissions.

What are the key skills and qualifications needed to thrive as a quality control analytical development manager?

To thrive as a Quality Control Analytical Development Manager, you need expertise in analytical chemistry, method development, and regulatory compliance, typically backed by a degree in chemistry or a related field and relevant industry experience. Familiarity with laboratory information management systems (LIMS), chromatographic techniques (HPLC, GC), and regulatory guidelines (GMP, ICH) is essential. Strong leadership, problem-solving, and communication skills enable effective team management and cross-functional collaboration. These skills ensure accurate testing, regulatory adherence, and the delivery of high-quality products in a competitive pharmaceutical or biotech environment.

What are some typical challenges faced by a quality control analytical development manager during method transfer and validation projects?

A Quality Control Analytical Development Manager often encounters challenges such as aligning analytical methods with regulatory requirements, ensuring method robustness across multiple laboratories, and managing tight project timelines. Effective communication and detailed documentation are crucial, as the role frequently involves collaborating with R&D, production, and regulatory teams. Additionally, troubleshooting unexpected analytical results and training team members on new techniques are common aspects that require both technical expertise and strong leadership skills.

What skills do you need to be a Quality Control Analytical Development Manager?

A Quality Control Analytical Development Manager needs strong analytical skills, expertise in laboratory techniques, and knowledge of regulatory standards such as GMP and GLP. Proficiency with analytical instruments, data analysis, and project management are essential, along with effective communication and leadership abilities. Certifications like a Six Sigma or relevant scientific degrees can also enhance qualifications.

What cities are hiring for Quality Control Analytical Development Manager jobs?

Cities with the most Quality Control Analytical Development Manager job openings:

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What are popular job titles related to Quality Control Analytical Development Manager jobs?

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Infographic showing various Quality Control Analytical Development Manager job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $81,324 per year, or $39.1 per hour.

Associate Director, Analytical Development and Clinical QC

New Haven, CT • On-site

AstraZeneca
Pharmaceutical Product Wholesalers • 10K+ employees
Learn more about AstraZenecaexternal

Full-time

Re-posted 10 days ago

Key responsibilities

  • Lead all aspects of analytical method validation, transfers, and compendia method verifications across all stages of clinical development and method life-cycle stages

  • Serve as the analytical lead for CMC programs, emphasizing late-stage programs, and collaborate with cross-functional teams to develop analytical strategies

  • Author regulatory submissions and respond to health authority queries related to analytical sections

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

23rd of 86 rated pharmaceutical

Job description

This position will play a key leadership role in Alexion's Late Stage Analytical team, which requires analytical expertise and proven success in management of development projects through the CMC lifecycle. This position will lead multiple projects in parallel and working closely with other PDCS teams, Regulatory, QA and external QC laboratories as a lead to designing the strategy of late-stage analytical activities including method transfer/validation, compendia method verification, and overall testing strategy throughout all phases of the product lifecycle. Moreover, this position will lead to authoring regulatory filing in relevant analytical sections with a focused understanding of country-specific requirements!
You will be responsible for:
  • Leading all aspects of analytical method validation, transfers, and compendia method verifications across all stages of clinical development and method life-cycle stages
  • Analytical lead for CMC programs, emphasizing late-stage programs, which may be internal or external with cross functional collaboration.
  • Analytical end-to-end strategy for key late-stage biologics programs including analytical control strategy, method lifecycle and QC testing supervision, problem resolution and inquiries, and key BLA/commercial analytical
  • Supervision of analytical QC testing, problem-solving, and data analysis are conducted for the CMC program. This provides oversight of the analytical program's health. It also helps identify potential analytical and program risks early.
  • Leading independently regulatory authoring for both medical and market-facing submissions for all markets including responses to health authority queries and requests for information
  • Agility / Adapatability (Changing direction as conditions shift) (reframing and pivoting, abandoning outdated approaches)
  • Learning Mindset (Learning, unlearning, and applying quickly) (Curiosity & feedback-seeking, transfer of learning, self-directed, growth mindset independent of role)
  • Agency (Taking ownership and driving action without waiting for instruction - making things happen) (Proactively identifying problems, acting without permission when needed, personal accountability for outcomes, persistence in overcoming obstacles)

You will need to have:
  • Advanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field with 8-12+ years of progressive experience in biologics analytical development across clinical and commercial stages
  • Validated first-hand expert knowledge and technical proficiency with monoclonal antibodies, bispecifics, fusion proteins.
  • Technical expertise in chromatography (e.g., SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding, potency), and residuals/impurities testing (HCP, DNA, residual Protein A)
  • Compendia method experience emphasizing USP, EP and JP compliance
  • Strong written and verbal skills for clear reports, regulatory submissions, and presentations to technical and non-technical collaborators
  • Demonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies.
  • Strong command of ICH (Q5E, Q6B, Q8-Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module 3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries.
  • Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness
  • Ability to define critical quality attributes (CQAs), build specifications, and implement control approaches aligned with Quality by Build (QbB)

We would prefer you to have:
  • Experience in microbiology assays (e.g., required day of harvest, bioburden, endotoxin, sterility, and CCIT)
  • Background in analytical method development and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as statistical data analysis and relevant tools
  • Experience leading all aspects of CDMO/CRO analytical activities including routine testing oversight, troubleshooting and investigations and method qualification, validation, and transfer.
  • Experience in country specific compendia requirements and knowledge of CHP
  • Experience leading ICH stability programs (Q1), shelf-life modeling, and projections and related statistical approaches.
  • Experience in extended characterization and comparability including forced degradation studies for process comparability.
  • Familiarity with LIMS, ELN, Chromatography Data Systems, data visualization, and automation/robotics in analytical workflows
  • Expertise with AI tools and statistical software, for example JMP
  • Track record of building, mentoring, and developing high-performing teams; resource planning, and performance management

The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees will work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
When we put unexpected teams in the same room, we ignite ambitious thinking with the power to encourage life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.
Join us in our outstanding and ambitious world.
Why AstraZeneca:
Here, courage, curiosity, and collaboration fuel a relentless focus on transforming cancer outcomes, powered by a pipeline that fuses cutting-edge science with advanced technology. You will work in an environment where unexpected teams come together to spark bold ideas, backed by meaningful investment and a clear path from discovery to impact. We value kindness alongside ambition, and we empower leaders at every level to ask sharp questions, take smart risks, and turn data into decisions that help patients sooner.
Date Posted
18-Jun-2026
Closing Date
30-Jul-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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About AstraZeneca

Sourced by ZipRecruiter

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. A place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Make a meaningful impact that brings real benefits to society. By applying your knowledge of data, you will help to redefine our industry and ultimately save lives. Work with experts who share a common goal: to accelerate the potential of medicines and the science of tomorrow.

Industry

Pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Cambridge, Cambridgeshire, GB

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