Senior Scientist, Bioanalysis

Position Summary:

We are seeking a talented and highly motivated individual to join the DMPK/Bioanalysis group at Apellis Pharmaceuticals in Waltham, MA. The main responsibility for this position is to outsource and manage non-clinical and clinical PK and ADA bioanalysis. This includes managing novel PK and ADA method development, method transfers and qualifications/validations for various molecules and matrices, being responsible for providing the PK and ADA results for clinical database locks, auditing and monitoring the specialty labs. This individual must own the role as PK and ADA BA expert at Apellis, work well independently, and should have a passion and track record of successful PK and ADA method development. The role will require literature research, interactive and effective communication to provide strategy and sample collection guidance for PK and ADA samples.

Key Responsibilities Include:

• Manage outsourced clinical and non-clinical PK and ADA bioanalytical method development, qualification/validation, sample management, sample analysis and data transfers at specialty labs.
• Contribute to operation management by running, preparing agendas and taking minutes for regularly scheduled meetings with specialty labs and other external vendors.
• Collaborate closely with colleagues in clinical operations, data management, quality to ensure timely PK and ADA sample analyses and accurate reporting and database locks.
• Work closely with QA in writing and overseeing the respective Quality Events, NTF and CAPAs.
• Participate as the subject matter expert in the routine audits of the specialty labs.
• Represent bioanalytical PK and ADA function at cross functional projects in Research and Clinical Development, striving to develop novel therapeutics to address unmet medical needs targeting the complement cascade.
• Contribute to building a data-driven scientific culture at Apellis.

Education, Registration & Certification:

• PhD in Biology, Chemistry or related field with 2+ years of bioanalysis experience.
• MS in Biology, Chemistry or related field with 5+ years of bioanalysis experience.
• BS in Biology, Chemistry or related field with 10+ years of bioanalysis experience.

Experience:

• Significant experience managing bioanalytical labs is required.
• Strong understanding of the bioanalytical method development / validation, clinical studies process, sample management and regulatory submissions is required.
• Experience with GxPs and quality management systems is required.
• Strong understanding of the drug discovery and development process.

Skills, Knowledge & Abilities:

• Independent individual willing to contribute where needed in a flexible and fast-paced environment.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail while executing corporate objectives and goals.
• Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
• Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing internal/external partnerships and cross-functional matrixed relationships.
• Strong interpersonal skills.
• Ability to present strategies and data to a broad range of audiences in a credible and engaging manner.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel.

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visithttps://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 visithttp://apellis.comor follow us onTwitterandLinkedIn

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.