Senior Manager, Device Development

Position Summary:

The Senior Manager Device Development will be a key contributor within our device development team and will support the development of drug delivery devices for our innovative therapies. The successful candidate will be expected to work independently and as an effective engaged team member in a fast-paced environment while collaborating with peers in a matrixed organization. Through the responsibility for the development of successful development activities this position will embody the Apellis values and be part of the team accountable for delivering impactful new ways for our complement-based therapies to improve the lives of our patients.

Preferred job location: Waltham MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.

Key Responsibilities Include:

• Lead end-to-end development of devices and combination products (e.g. pre-filled syringes autoinjectors wearable injectors) from need through commercialization.
• Collaborate with cross-functional teams (Technical Operations Quality Regulatory Manufacturing Human Factors Clinical) to align technical and strategic goals.
• Develop and maintain project timelines budgets and risk management plans.
• Manage external development partners contract manufacturers and other external resources.
• Ensure compliance with applicable regulatory requirements (e.g. FDA 21 CFR Part 820 ISO 13485 EU MDR).
• Oversee design control activities including design verification and validation risk management (ISO 14971) and human factors engineering (IEC 62366).
• Author and review technical documentation including design history files regulatory submissions and technical reports.
• Provide technical presentations at functional and multi-functional settings.
• Anticipate challenges and develop mitigation strategies to keep deliverables on pace.
• Participate in and support regulatory submissions (IND NDA BLA 510(k) PMA CE marking).
• Stay informed of industry trends technological advancements and changes in regulatory landscapes.
• Other duties as assigned.

Education Registration & Certification:

• Bachelors Degree in Mechanical Engineering Biomedical Engineering Electrical Engineering or similar.

Experience:

• 7 years of progressive experience as an engineer developing medical device or preferably combination products.

Skills Knowledge & Abilities:

• Experience with combination product development is highly desirable.
• Experience with sterilization especially low temperature modalities) is highly desirable.
• Deep knowledge of product development processes including design controls and risk management.
• Strong leadership communication and organizational skills.
• Ability to work cross-functionally and influence without direct authority.
• Familiarity with relevant standards and guidance documents (e.g. ISO 11608 FDA Guidance for Combination Products).
• Execution of device design verification and validation authoring documentation associated with Design Controls.
• Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
• Demonstrated ability to project manage technology transfer and/or new product launches.
• Excellent organizational written and verbal communication & negotiation skills.
• Experience with CAPA FMEA and RCA tools in a highly regulated manufacturing environment.
• Experience in managing external vendors and global teams.
• May require occasional travel (domestic/international) to partner or manufacturing sites.

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 and bend or stand on a stool as necessary. 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 expected.

Benefits and Perks:

Base salary for this role will consider multiple factors including but not limited to candidate qualifications relevant expertise specialized skills and industry experience in complement-targeted therapies.

The targeted base salary range for this position is $148000 - $221000 per year. This range represents the base salary only and reflects Apellis commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications business needs and current market conditions.

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:// 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 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.