Manager, quality control laboratory job description

The QA department is hiring! Join this newly formed team and own the Quality function as it relates to support of our Quality Control Laboratories The individual will proactively identify and lead all aspects of implementation of industry standard processes for GMP across the quality control operations. This position will play a key role in influencing policy and procedure and promoting continuous improvement in the organization.
As a Manager, Quality Compliance, a typical day might include the following:

* Interacts primarily with Quality Control laboratories (and other support functions such as Manufacturing, Process Sciences, QA Validation, IT, Facilities) to ensure a successful compliance profile.
* Leads all aspects of quality standards, systems, and metrics for laboratory operations and related manufacturing areas.
* Accountable for the performance, results, and timeliness of team.
* Ensures that procedures and products adhere to internal standards as well as those of the agencies that regulate the pharmaceutical industry around the world.
* May be involved in ensuring regulatory observations are adequately addressed and completed on schedule.
* Acts as a key quality assurance resource on matters related to Quality Control and as a leader between functional areas to ensure regulatory compliance.
* Collaborates with key partners globally in the business to proactively identify areas for improvement, develop solution strategies, and implement new innovations.
* Finds opportunities and participates cross-functionally to develop and implement tools and processes to improve systems, alleviate constraints, and resolve issues.
* Gains cooperation of others and effectively facilitates the resolution of cross-functional issues. Ensures effective, accurate, and timely communication across functional areas serving as a point of contact for Quality Assurance.
* Identifies areas of global mis-alignment and participates cross-functionally to understand differences, assess gaps, and drive relevant actions to remove gaps.
* Provides guidance and mentoring to co-workers to assist with troubleshooting, investigations, and effective problem resolution.
* Ensures safety and operational standards are maintained.
* May manage a team of individual contributors to support team goals.

This role may be for you if:

* Good understanding of analytical laboratory and biologics manufacturing operations is helpful; experience with facility or laboratory start-up, technology transfer, validation, Pre-Approval Inspections, and product launch activities
* Prior experience within a Quality Assurance or Quality Control function
* Good interpersonal skills and attention to detail
* Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
* Ability to handle multiple assignments and changing priorities.
* Ability to learn and apply computerized systems for daily performance of tasks
* Ability to prioritize, manage multiple tasks, and meet deadlines

In order to be considered for this position, you must hold a BS in life sciences subject area or related field and

* Manager: minimum 7 years experience in pharmaceutical industry with 2+ of those years to include leadership and/or supervisory experience
* Senior Manager: minimum 8 years experience in pharmaceutical industry with 2+ of those years to include leadership and/or supervisory experience
* Experience in the pharmaceutical/biotechnology industry (biotech preferred) desired

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

#REGNQA #LI-Hybrid

**Why Patients Need You**

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

**What You Will Achieve**

In this position, you will be joining our Quality Operations department which performs critical Quality Control activities, through collaboration with supporting Quality Control (QC) Laboratory and Manufacturing teams. Your work will help the department to build the capabilities and systems to run a more robust Laboratory operation including the organization of long range manpower forecast and finite planning around department specific and routine QC Laboratory operations.

As a Manager, you will be setting the objectives for multiple projects in your division. Your managerial and technical skills will help in guiding the people in your division. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the division and sets direction for its success.

Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.

**How You Will Achieve It**

+ Set objectives for and manage multiple projects/ ongoing work activities within Operating Unit.

+ Provide support as needed to Quality Operations, Production and Engineering to assess product and process aseptic issues.

+ Participate in internal and external quality assurance assessments and in the assessments of contract operations that supply drug products to Pfizerlocationsif required.

+ Ensure the timely release of raw materials, in-process, final product materials and stability samples to support operations and compliance with the respective licensed specifications.

+ Ensure standardized Quality Control (QC) practices and systems across all QC functional areas and drive the implementation of Operational Excellence best practices and tools in support of an efficient QC operation.

+ Responsible for closing the Gaps between Pfizer Quality Standards and QC practices.

+ Establish, recommend, maintain and assure that consistent laboratory procedures and practices are followed in accordance with company policy and regulatory requirements.

+ Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.

+ Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement.

+ Support continuous process performance evaluation and continuous process improvement for highest effective and efficient process operations.

+ Manage, develop and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.

+ Ensure the delivery of an excellent customer service to all internal and external customers of the quality control department.

**Qualifications**

Must-Have

+ Bachelor's Degree and 7+ years of experience.

+ People Management experience.

+ Excellent verbal, written and interpersonal communication and presentation skills.

+ Strong knowledge of analytical chemistry, instrumentation, laboratory automation and production processes.

Nice-to-Have

+ Master's degree and relevant pharmaceutical experience.

+ Strong and thorough knowledge and understanding of GMP, GLP.

+ Comprehensive knowledge of LIMS and laboratory equipment.

+ Knowledge of six sigma, lean labsand standard work practices.

+ Experience in Empower software.

+ Experience leading people leaders and directing a large, complex organization.

Relocation support available

**Last Date to Apply: Oct 14 2022**

Relocation assistance may be available based on business needs and/or eligibility.

**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control

Kelly Scientific is recruiting for a Manager of Analytical Development and Lab Quality Control in W. Lafayette, IN. This is a direct hire (perm) position.
**JOB TITLE: MANAGER OF ANALYTICAL DEVELOPMENT AND LAB QUALITY CONTROL**

**Reports to: Chief Executive Officer**

**Location: W. Lafayette, IN**

**Working Schedule: Monday - Friday, 8 AM - 5 PM**

**Compensation Rate: 90k - 100k depending upon level of experience**

**POSITION SUMMARY**

This position is responsible for developing testing procedures to evaluate and characterize nanoparticles for all therapeutic applications of strategic importance to the company. This position will develop testing procedures and a lab quality system for all tests and experiments on nanoparticles. This individual will also assist in particle formulation and the transition of process to contract manufactures as part of the scale-up of GMP production.

**KEY RESPONSIBILITIES**

Develop and execute Analytical testing procedures:

+ Lead analytical testing for our proprietary poly-bile nanoparticle platform across a variety of therapeutic areas.

+ Serve as technical expert for the continued development of poly-bile nanoparticle platform. Participate in business development discussions and due diligence activities.

+ Plan, design, and execute protocols; record, interpret and report results for complex studies. Integrate formulation development with PK and drug distribution study design.

Support Polymer and Nanoparticle production:

+ Work closely with Director of Development to formulate and produce material required for studies and partnerships

Quality System Development:

+ Establish and manage the quality system for the development lab. Lead development of testing procedures and creation of SOPs. Ensure lab documentation that conforms with company quality systems and partner expectations.

+ Provide technical guidance to contract manufacturer in process development and scale-up of GMP production. Guide the design, development and transfer of a new methods and formulations to manufacturing operations.

+ Provide recommendations to management on key technical capabilities needed for manufacturing testing

**QUALIFICATIONS**

+ Ph.D. Chemistry, Biochemistry, Drug Delivery, Engineering or other relevant fields with 5+ years of experience in nanoparticle drug delivery and development experience.

+ Significant experience in the development of analytical measurement

+ Understanding of and experience in development of lab quality systems

+ Analytical instrumentation including (pH, HPLC, UV-Vis, NMR, LC/MS), zeta-potential and particle sizing, HPLC and GC techniques, dissolution testing

**Additional Skills/Preferences**

+ Excellent organizational and project management skills. A proven history of driving projects to completion and achieving project timelines

+ Entrepreneurial and innovative approach to science/engineering; good judgment, risk taking and intuition

+ Experience with working in a networked technical organization with proven skills in collaboratively working with suppliers and alliance partners.

+ Ability to effectively influence, to gain commitment within team, cross-functionally, and across levels

+ Ability to work within a team and as a strong team player

+ Strong collaboration, communication, and interpersonal skills to work effectively with a wide range of internal/external partners

+ Working knowledge of compliance issues and regulatory requirements

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** ** ** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ** **

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.