Associate Director – Analytical Quality Control Jobs

Excellent interpersonal skills with ability to work effectively with individuals at all levels (i.e. Management, CM, Development, etc.)

Apply software testing skills to ensure high quality software in multiple domains

Experience in developing comprehensive and accurate test designs and plans

Experience designing and executing black, white and gray box test conditions

Strong verbal and written communication skills

Experience with a comprehensive set of testing types, including unit, regression, integration, freestyle, and acceptance testing

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Proven ability to function in multidisciplinary cross functional team environments using clear communication and matrix management skills.

Excellent self-management, organizational, and verbal/written communication skills.

PhD in chemistry, biochemistry, or closely related field, or equivalent experience applicable to the job responsibilities

Industry experience that includes transition of early-stage QC methods to late-stage programs including preparation of regulatory filings.

Experience with vaccine development and interactions with the Essential Regulatory Laboratories, desired

Must possess strong organization skills

Perform documented methods required for finished product quality testing

Review manufacturing documentation for process deviations

Communicate analyzed results in detailed written reports.

Maintain archive of control sample inventory required for product testing

Maintain accurate and detailed records

Determine if incoming orders match criteria as stated on the purchase order, and if a problem exists, inform the QC Manager.

Perform miscellaneous duties as assigned by the QC Manager.

Inspect incoming orders to ensure quality of merchandise meets established standards.

Attach scanned labels to corresponding cases.

Resolve any discrepancies that might exist between quantities received and quantity stated on the vendor ASN.

Ability to talk and hear

At least 3 years of management experience required

Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues

Oversee and conduct cGMP, ICH, and ISO stability programs to comply with regulatory requirements

Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees

Master's Degree in Chemistry or Chemical Engineering with a minimum of 5 years work experience in GMP manufacturing required or

Bachelor's Degree in Chemistry or Chemical Engineering with a minimum of 8 years work experience in GMP manufacturing required

Experience with the technical transfer and qualification/validation of analytical assays.

$34.00 (entry-level qualifications) to $39.00 (highly experienced)

Lead the testing of assigned lot release and stability samples to meet expected turnaround time requirements.

Participate in method qualification, validation and transfer activities.

Support instrument installation and operational qualification activities (IOQ).

Ensure a compliant work space by adhering to and enforcing GxP requirements.

Maintain compliance with applicable ICH, GLP, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.

Record data per GxP requirements. Provide peer review of documentation as needed.

At least 1 year of experience in GMP pharmaceutical environment.

Senior Manager Quality Control, Biologics CMC

Perform sampling, testing and release of raw materials and in process testing.

Perform testing as per current approved test method and maintain accurate laboratory records and adhere to cGMP/GDP expectations.

Experience with Laboratory Information Management System (LIMS)

Basic computer skills (data entry and attention to detail) in Microsoft

Excellent effective written and verbal communication and interpersonal skills

Experience in biotech or pharmaceutical industry

Experience leading continuous improvement projects.

Laboratory experience, including HPLC with Empower

Strong execution capability, time-management skills, and multi-tasking; ability to quickly shift priorities in support of production needs

Executes additional duties and responsibilities as assigned

Minimum 2 years of work experience in manufacturing

Every employee is offered lean manufacturing and 5s training

We offer quarterly production bonuses

Great benefits including 10 days paid time off, insurance, 401k, and more!

Demonstrated leadership and management of high-performing teams.

Experience developing and optimizing cell-based assays with demonstrated breadth of understanding around factors influencing their performance.

Experience with ligand-binding assay development and performance (ELISA, MSD, FACS, Luminex, other)

Experience with Regulatory filings and/or agency interactions (IND, BLA, MAA and RTQ).

Experience with bioassay development and defining potency testing strategy for biotherapeutics.

Experience with mRNA or other gene therapy modalities

Understanding of scientific principles, ability to communicate with peers and management.

Participates in the execution of method/material qualification and analytical improvement projects.

3+ years of relevant experience (B.S. Degree), 6+ years of relevant experience (A.S. degree)

Solid working knowledge of operations/quality systems utilized in QC operations/support teams (e.g. strong test method/scientific base).

Provides timely review of data and documentation generated for or by QC.

Ability to perform color differentiation testing.

Perform other duties as needed or directed by direct manager/supervisor and/or the leadership team

Degree in ecology, biology, or marine related field or 1+ years of experience in aquaculture, lab, or other scientific setting

Ability to learn and use various digital systems (e.g. Excel, Google Suite, remote sensor monitoring systems)

Ability to use math skills in performing duties

Daily microscopy, documentation, and assessment reporting of algal cultures with respect to biosecurity and production targets.

Perform duties accurately and according to protocols, providing optimal care to the algae independently and with minimal supervision, once trained

In addition to competitive compensation, we offer a comprehensive benefits package including:

Manage investigations and troubleshoot existing methods to assess impact of out of specification materials of finished product.

5+ years of experience working as a leader in a GMP laboratory.

Outstanding verbal and written communication skills.

Intermediate to expert level administrative knowledge of MS Office applications; proven ability to leverage digital technology and resources.

Proven ability to successfully manage projects and timelines, organize/track information, prioritize accordingly.

Knowledge of inventory management/ERP systems and Microsoft Office products.

Minimum of 2-5 years of relevant work experience required.

1+ years regulated GMP environment experience required.

Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.

Assure all Materials Control staff are current on existing compliance and training requirements, as well as industry best practices

Other duties, as assigned in accordance with company requirements.

Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment

Establish a lab operation compliant with Lilly Global Quality Standards and regulatory requirements, including establishing lab practices, procedures, test methods, etc.

Bachelor of Science in Biology/Microbiology or related work experience

Minimum 5 years of pharmaceutical leadership experience including leading or working effectively with a cross functional groups

Minimum 5 years GMP lab experience including microbiological testing, environmental monitoring, and method transfer

Deep understanding of compliance requirements and regulatory expectations

Previous working experience in the lab, sample management, aseptic techniques, and cell culture activities are highly recommended.

Executes QC sample management activities, which include receipt, inventory sample entry, sample distribution, sample label creation, sample coordination/shipment preparation, and disposal.

Performs routine maintenance of laboratory reagents/materials orders and inventory management.

Should be able to manage the workload, meet deadlines, be eager to learn new techniques, and demonstrate good organizational skills.

Basic understanding of Good Laboratory Practices (GLP) with strict adherence to cGMP requirements is essential.

Dependable, able to learn new skills rapidly, and able to work well within the team.

Minimum Qualifications – Education And Experience

Preferred Qualifications – Education And Experience

Other projects or responsibilities as may be required.

1-3 years of previous experience in a laboratory setting

Familiarity with basic lab equipment and knowledge of lab safety protocols

Excellent organization, communication, and problem solving skills

Knowledge of current regulatory guidelines and cGMP requirements.

B.S. or Master degree from an accredited university is required. Working experience in the pharmaceutical or biotech industry is preferred.

Practical knowledge of method development and optimization for protein therapeutics is preferred.

High emotional intelligence, excellent interpersonal skills, and strong communication skills.

Follow and execute defined methods, SOPs. Under direct supervision, author SOPs, study plans, protocols, and method development reports.

Work with various Research and Development teams to support transfer of analytical test methods for development and clinical support.

Excellent reading / writing and communication skills.

Must be willing to take a drug test and post-offer physical (if required)

Responsible for compliance with industry guidelines and governmental regulations, preparing, auditing, and reviewing test methods, test records and other GMP

Documentation, hosting inspections and audits of the QC areas. Establishes and maintains quality agreements with vendors, third-party manufacturers, and contractors.

Directs the oversight of data integrity with instrumentation and manual processes used throughout the Quality Control laboratories.

Responsible for compliance with industry guidelines and governmental regulations, preparing, auditing, and reviewing method test records and other GMP

Preferred Qualifications – Education and Experience

Other projects or responsibilities as may be required.

1-3 years of previous experience in a laboratory setting

Familiarity with basic lab equipment and knowledge of lab safety protocols

Excellent organization, communication, and problem solving skills

Experience with some of the following applications: flow cytometry, western blotting, Immunoprecipitation, bioassays, ELISA and IHC/ICC