Job description

• Job Title: Manager/Senior Manager/Associate Director, Quality Control
• Department: Quality Control
• Reports to: Director, Quality and Regulatory Affairs
• Direct Reports: Currently four (4) QC Analysts
• Work Hours: Full time
• FSLA Status: Exempt
• Job Number: 9020

Job Summary:
The Manager/Senior Manager Associate Director - Quality Control will report to the Director - Quality and Regulatory Affairs. In this leadership position you will develop and lead the Quality Control (QC) group and manage all QC functions and activities. The functions of the QC department include, but are not limited to, performing QC testing of DS/DP release and stability samples in support of BioFactura programs ensuring compliance with established standards; cross-training with Analytical Development (AD) to enable assay transfer to QC and assay validation activities; and authoring and review of method SOPs, protocols and reports.

Responsibilities:

• Serving as a key member of the BioFactura Quality leadership team.
• Qualifying and validating (as appropriate) methods for GMP release of monoclonal antibodies and other protein biologics.
• Staffing, training, developing employees professionally and conducting annual performance reviews.
• Reviewing and compiling environmental monitoring data as well as assisting with trending.
• Ensuring the safety of lab personnel by identifying and correcting unsafe conditions in office and lab spaces.
• Translating testing regulations, requirements, and guidelines into policies and practices that support GMP operations.
• Managing the overall laboratory compliance strategy for BioFactura laboratories.
• Determining necessary testing requirements for critical quality attributes (CQAs) for GMP manufacturing runs.
• Generating clinical product (DS, DP) specifications, authoring critical reagent material specifications, and making recommendations for corrective action(s) necessary to ensure conformity.
• Scheduling and providing technical oversight of testing performed internally and via external contract testing laboratories/CMOs/CROs.
• Participating in facility expansion, providing QC strategy and support in the design and development of laboratories and new testing capabilities.
• Outlining objectives, identifying continuous improvement initiatives, monitoring progress of deliverables, and providing support to manufacturing and development functional areas.
• Establishing processes (e.g. sample tracking, stability program), analytical equipment work instructions, standard test methods, and associated forms.
• Evaluating regulatory requirements for biosimilar quality assays and incorporating that information into assay development and QC plans.
• Leading technology transfer of methods to CMOs and/or strategic partners.
• Working with CMOs’ and/or strategic partners’ QC and manufacturing teams to ensure assay control in GMP environment.
• Working across functional areas such as research, development, clinical, regulatory, and manufacturing to enable critical decisions across the BioFactura portfolio.
• Managing the day-to-day cGMP laboratory activities of QC analysts and scientists directed toward accurate and timely release testing of raw materials, intermediates, bulk and finished products.
• Providing senior scientific leadership and setting strategic direction of technology advancement.
• Reviewing and finalizing SOPs, protocols, method validations, stability studies and analytical reports that meet all applicable regulatory requirements.
• Working closely with process development and other science teams to deliver analytical results for process decision making and regulatory needs.
• Reviewing and approving sample collection procedures, storage and transmission specifications for GMP protocols, system suitability controls, assay raw material specifications, and all GMP test methods at site and CMOs.
• Conducting comparability assessment (as needed) for any changes made to qualified/validated assays.
• Contributing to relevant analytical sections of IND/BLA and other regulatory documents.

Required Skills/Abilities:

• 5+ years of experience with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a biopharmaceutical QC setting
• Minimum of 1-year of experience managing one or more direct reports
• Hands on experience in protein analytics including HPLC, CE and/or immunoassays
• Ability to collaborate with peers on day-to-day tasks; cooperative and works well with a team to ensure timelines are met
• Strong attention to detail
• Excellent time management and proven ability to complete projects on time
• Must be organized and self-motivated
• Must feel comfortable leading and guiding the QC team, as well as educating management, development, and manufacturing colleagues to progress the Quality culture
• Must have excellent communication, presentation, and technical writing skills
• Strong understanding of regulations governing documentation, data collection and data integrity.
• Strong level of initiative and quest for knowledge
• Strong experience in biologic’s intermediate, release and stability testing.
• Ability to prioritize and manage tasks and operational flexibility.
• Ability to function well in a high-paced and at times stressful environment.
• Must love to learn!

Physical Requirements:

• Prolonged periods of sitting at a desk, working on a computer and scientific lab bench.
• Must be able to lift up to 20 pounds at times.

Education:
Bachelor diploma or higher

About BioFactura:
BioFactura develops and commercializes biodefense drugs, novel drugs, and high-value biosimilars (i.e., follow- on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal choice for bringing these products to market with faster, lower cost, superior-quality manufacture. For over 10 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.

To Apply:
Complete online application (Apply) www.biofactura.com

BioFactura is a participant of E-verify.

BioFactura provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job Type: Full-time

Pay: $150,000.00 - $175,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay
• Signing bonus

Ability to commute/relocate:

• Frederick, MD 21701: Reliably commute or planning to relocate before starting work (Required)

Experience:

• cGMP and GDP in a biopharmaceutical QC setting: 5 years (Required)

Work Location: Hybrid remote in Frederick, MD 21701

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