- Develop SOPs, guidance, protocols, and reports that meet requirements of GMP and appropriate regulatory guidelines.
- Develop and validate analytical methods for testing raw material and formulated pharmaceutical products in solid and liquid oral dosage forms.
- Perform analytical testing using established in-house and USP analytical methods.
- Manage the day-to-day activities for all R&D method development, transfer, validation, early-phase formulation development, and finished product testing, including:
- Assay, related substances, impurities, uniformity of dosage units, dissolution, residual solvents, loss-on-drying, microbial testing, cleaning verification and validation.
- Container/closure testing and selection
- Conduct stability-indicating studies per USP and ICH guidelines.
- Perform installation qualification, operational and performance qualification for new instrumentation.
- Spearhead both short- and long-term strategic planning for lab space, infrastructure, and data accessibility.
- Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase and commission of analytical instrumentation.
- Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
- Stay current on publications released by USP, FDA, and other pertinent regulating bodies to ensure activities throughout the facility are compliant and continuously improved upon.
- Develop assay, degradation product and dissolution methods to support product development
- Perform drug product testing to support formulation and process development
- Perform method validation per ICH Q2(R2)
- Perform routine stability testing for drug products
- Maintain accurate records of laboratory studies
- Assist in developing specifications and test methods, as needed.
- Review analytical raw data and documents
- Work simultaneously on multiple projects
- Perform maintenance and calibration of laboratory equipment
- Perform related duties, as assigned
- Formulate a comprehensive lab contract service strategy and establish agreements.
- Manage budgets for service contracts, repairs, and equipment maintenance.
- Implement efficient planning and scheduling to minimize equipment disruption.
- Oversee asset life-cycle management with attention to budget efficiency.
- Staff Training and Competency:
- Conduct thorough staff training and ensure the certification of competency.
- Supervise work processes to guarantee precision and efficiency.
- Ensure meticulous handling of testing samples from receipt to organization and preparation.
- Address initial troubleshooting of testing issues and report problems promptly to leadership.
- Ensure unwavering adherence to all QA/QC protocols and validate compliance.
- Responsible for investigating and processing Deviations, Out-of-Specifications, Out-of-Trend, and QC events.
- Possess a deep understanding of ISO 17025 standards, 21 CFR, US FDA guidance, ICH guidelines, and compendia requirements.
- Assist in developing and executing the best laboratory operations plan with a focus on scientific supplies management.
- BS in Chemistry, Pharmaceutics or Chemical Engineering
- A minimum of 1-3 years of HPLC experiment
- Working knowledge of laboratory instrumentation like HPLC, UV, Dissolution etc.
- Knowledge of chromatography data systems, such as Waters Empower, HP Chem Station or other laboratory software.
- Computer literacy in Windows applications and MS Office.
- Demonstrated excellent technical writing and verbal communication skills.
- Maintain a safe working environment, ensuring compliance to all local, state and federal regulations.
- Excellent attention to detail, compliance and quality
- Self motivated individual with the ability to learn, lead and contribute to the team.
- Must be able to lift at least 50 lbs.
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Analytical Lab Manager - Miami, United States - Meds
Description
Analytical Lab Manager
Overview
We are a fast-growing healthcare technology company seeking an experienced Analytical Lab Manager who has previous experience spearheading the buildout of a new lab from the ground up and is ready to do it again, as well as support continuous operations thereafter.
The ideal candidate will be based in or near Fort Lauderdale, FL, and should be comfortable with traveling as needed to existing locations, including the Chicago, IL area. In Chicago, the candidate will initially assist in developing an internal lab practice, while simultaneously overseeing the construction of a new lab in Florida. The successful candidate will have a strong understanding of 21 CFR, US FDA guidance, ICH guidelines, and the requirements for IND and ANDA submissions for prescription pharmaceutical small molecules.
Candidates should possess excellent time management, organizational, and planning skills, with the ability to multitask, prioritize, and manage timelines in a fast-paced environment. Attention to detail and maintaining a high level of accuracy are crucial, as well as the ability to meet deadlines for assigned projects.
Lab testing services will include API analysis, as well as pharmaceutical R&D functions.
Responsibilities and Duties
SOP Development:
Workflow Enhancement:
Strategic Vision:
Contract Service Strategy:
Budget Oversight:
Sample Management:
QA/QC Compliance:
Scientific Supplies Management:
Qualifications
We offer a competitive salary, benefits package, and a collaborative work environment that fosters creativity and professional growth. If you are looking for a great opportunity, we encourage you to apply and become a valuable member of our team.
