Provides leadership, scientific and technical expertise to develop testing solutions in support of Alpine's development programs. Supports regulatory filings and correspondences. Key to success will be technical collaboration and integrated planning with internal cross-functional teams as well as external contract research organizations (CROs), to complete planned analytical activities in accordance with corporately agreed scope, timing and budget.
The title/level will be commensurate with experience and qualifications.
· Conception, implementation, management and analysis of a diverse range of bioanalytical and biological testing for protein-based drug candidates in support of clinical, CMC and preclinical pharmacology activities.
· Lead method development and phase appropriate qualification/validation of bioanalytical (bioassay, binding, and impurities) assays as well as transfer of methods to CROs
· Responsible for CRO evaluation, selection and management. Participate in vendor audits, train personnel and lead troubleshooting and investigations for bioanalytical methods
· Support analytics across the entire product lifecycle, providing scientific and technical oversight and/or contributing hands-on to technical activities, at the CRO and Alpine labs during method development, qualification, transfer and validations
· Collaborate in cross-functional teams on projects, establish and improve product knowledge and quality
· Directly responsible for reviewing assay reports and data generated for bioanalytical methods
· Responsible for preparing dossiers and data packages and providing input for interactions with regulatory agencies. Interact with regulatory agencies, participate in audits/inspections, and prepare draft responses
· Develop, revise and review SOPs, qualification/validation protocols, and reports
· Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies and identify and influence continuous improvement opportunities across the organization as appropriate
· MS or Ph.D. in Analytical Chemistry, Biochemistry, Protein Sciences or related field, with 10+ years experience in bioanalytical development for biologics
· In-depth and strong knowledge of bioassay development and experience with method validation.
· Large molecule experience and proven experience with GLP/GxP is required
· Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) with experience in preparing and defending regulatory filings
· Proven ability to manage and negotiate projects and work with cross-functional teams comprised of internal and/or external contacts, including CROs
· Previous experience with data trending and statistical programs (JMP, MiniTab, Excel, etc.) preferred
· Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third-party contract organizations
· Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
· Proven ability to work with a high level of integrity, accuracy, and attention to detail
· Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on time and budget
· Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
· Entrepreneurial, enjoys working in a fast-paced, small-company environment
· Ability to work independently, under minimal supervision, and with the flexibility to handle workflow in a multi-tasking environment