Analytical Chemistry Director
The Wellington Group has been engaged to find an experienced Analytical Chemist Director with a proven background in the development of analytical methods for pharmaceutical or biological drug-based products. Excellent opportunity to make an immediate impact with great company…put your skills in chemistry, pharmaceuticals, scientific analysis and leadership to work in a new role today!
Analytical Chemistry Director responsibilities include:
- Responsible for analysis and validation of all raw materials, in-process materials, final product and stability studies both in-house and vendor / off-site work
- Development and validation (method development and validation) of analytical methods and assays to support the drug development, product development, product characterization, product pipeline and commercialization of all products produced
- Manage the laboratories, staff, hiring, training, mentoring and any oversight of third party analytical lab vendors and services
- Develop and writes SOPs
- Provide technical support and subject matter expertise, both internal and external
- Work with new drug product and/or drug containing products and combined therapies
- Responsible for writing scientific reports, papers and technical documents as well as supporting various regulatory filings for new products
- Will work with established QA Team to ensure all procedures are completed and documented to internal company standards and that all 3rd party labs and vendors meet quality compliance
The qualified Analytical Chemistry Director candidate will have:
- Proven, hands on skills with HPLC, MS, GC, LC/MS, FTIR, UV-VIS
- 8 to 10 years of analytical work and scientific analysis, or pharmaceutical or drug-products or drug-containing development work, can include time in post-doc work
- Experience with API / NCE / dug product development involving large molecules, proteins, amino acids, and/or rampamycin is a plus
- Development, qualification, troubleshooting and validation of analytical methods used in drug or drug-containing product development, regulatory submission(s) and commercialization is required
- Proven expertise in characterization and degradation is required
- Hand-on knowledge with SEC and biochemistry technical such as ELISA, Western Blot, Gels is a plus
- Experience working with R&D and clinical research material / products
- Strong verbal, written communication and organizational skills
- PhD in Chemistry or related field of study required (please provide details on your post-doc experience)
- Capable of managing and mentoring a laboratory staff, deadlines and a budget
- Knowledge of and training in GLP, GMP, and USP guidelines and regulations
Industry: Drug Discovery, Protein, Rampamycin, analytical chemistry, PhD, HPLC, method development, method validation, characterization, degradation, medical device, pharmaceutical, large molecule
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)
The Wellington Group ( https://twgrecruiters.com) 910-338-2795