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Position Summary
Apellis is seeking a highly motivated DMPK scientist with excellent knowledge and experience in LC- MS bioanalysis and ADME disciplines. The main responsibilities for this position are contracting, managing and overseeing outsourced bioanalytical and ADME activities for both early Translational and Non-Clinical Development programs (40/60). This includes working with small molecules, proteins, and oligonucleotides. The individual will also be part of the Translational Development group that is focused on developing novel therapeutics to address unmet medical needs targeting the complement cascade. This individual should possess excellent collaborative verbal and written communication skills and be able to work well with multi-disciplinary teams.
Key Responsibilities Include
• Contract, manage and oversee outsourced non-GLP and GLP bioanalytical activities at CROs.
• Provide scientific guidance both internally and externally on method transfer/development, qualification/validation, and sample analysis.
• Design, selection/set-up, and execution of the appropriate in-vitro/in-vivo studies to address all ADME/DMPK aspects through early discovery, candidate nomination, and early clinical development.
• Provide quality data, presentations, and regular updates to project teams.
• Author, review, and or QC written nonclinical reports including support for regulatory submissions, when needed.
• Assist in troubleshooting and routine sample analysis of established bioanalytical methods to the Apellis Innovation Lab as needed.
• Contribute to building a data-driven scientific culture at Apellis.
Education, Registration & Certification
• PhD in Pharmacy, Chemistry, Biology, or related field with 3+ years of industrial BA/DMPK experience.
• MS in Pharmacy, Chemistry, Biology, or related field with 5+ years of industrial BA/DMPK experience.
• BS in Pharmacy, Chemistry, Biology, or related field with 8+ years of industrial BA/DMPK experience.
Experience
• Excellent understanding of ADME principals is required.
• Hands-on experience with bioanalytical techniques such as LC-MS/MS, HRMS, or LBAs is required.
• Experience managing CROs is required.
• Experience with oligonucleotide ADME/Bioanalysis is a plus.
• Experience with PK/PD modeling and human dose/PK projection techniques is desired.
Skills, Knowledge & Abilities
• Strong interpersonal skills.
• Proven track record in collaborating with a diverse group of people in different locations and of different backgrounds.
• Excellent verbal and technical communication, independent scientific thinking, with the ability to interpret results, determine next steps and present data to project teams
• Highly motivated with the ability to be flexible in a fast-paced environment.
Travel Requirements
• 20% travel expected.
Benefits And Perks
Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://apellis.com/careers/ to learn more.
Company Background
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn
EEO Statement
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
