Director, Small molecule BA
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Director, Small molecule BA will be a strong leader to oversee a group of scientists who will be accountable for small molecule, oligo peptide method development, validation and sample analysis in the regulated environment. You will manage all the projects within the small molecules department on daily basis to ensure the quality, timeline and deliverable are met.
Role & Responsibilities
- Provide strong technical support to the team on different assay formats. Ability to trouble-shoot and solve technical issues.
- Review bioanalytical documentation that includes study protocols, method validation plan, sample analysis plans, data packages, validation study reports and sample analysis reports.
- Act as the main point of contact for biologics projects, discuss the projects with clients, and provide timely communication and updates internally and externally.
- May prepare and present proposals to the clients
- Write and update SOPs. Maintain GLP compliant PK and immunogenicity Labs.
- Support Business Development including reviewing proposals and meeting with new clients.
- Ensure delivery of high-quality bioanalytical data and regulatory documents (IND, BLA, global filings) as well as health authority interactions and scientific contributionsMaintain up to date knowledge of applicable scientific trends & technologies as well as industry regulations.
- Ensure new bioanalytical technologies are being assessed and incorporated when appropriate.
- Manage several concurrent responsibilities and projects
- Provide mentoring and career development of staff, and other employees as requested
- Hire, conduct performance reviews, train staff on laboratory procedures Ensure regulatory compliance and scientific oversight of bioanalytical programs
- Ensure a safe work environment is maintained at all times
- PhD in Analytical Chemistry, or related field and a minimum of 10 years of directly-related experience
- Hands-on experience in LCMSMS method development & trouble shooting.
- Experience with oligo peptides and biomarkers is a plus
- Experience in managing, training and developing advanced scientific personnel
- Strong experience and knowledge of method development / validation for supporting regulated studies
- Excellent communication and interpersonal skills and project management skills.
- Solid knowledge of GLP practices for bioanalytical laboratories and familiarity with ICH, FDA and EMA guidance, as well as USP and industry suggested best practices, regarding bioassay advancement and management
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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