Senior Director, Regulatory CMC
2 weeks ago
Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing. You will be joining at an exciting time when Just-Evotec Biologics is making game changing advances in biologics discovery, development and manufacturing. The primary responsibilities are to develop and execute global (with an emphasis on US and EU) CMC regulatory strategies towards regulatory adoption of innovative approaches to biologics product and process design, and manufacturing; to lead and manage CMC matters for internal and external products and
programs.
The Director of Regulatory CMC will have oversight for planning, preparation, and execution of CMC-related communication and documentations for engagement with regulatory authorities. The successful candidate will possess strong interpersonal and team skills to advise and persuade internal and external stakeholders.
Responsibilities:
With an emphasis for the US and EU, interpret global CMC regulations and provide strategic direction and regulatory guidance that are relevant to biotherapeutic technologies, products and systems being developed by Discovery, Process Development, Quality and Manufacturing
Regulatory input on the design of the J.POD commercial multi-product and multi-modality manufacturing facility
Coordinate appropriate meetings such as with the FDA Emerging Technology Team to discuss, identify and resolve potential regulatory issues regarding the design and operations of J.POD manufacturing
Lead and coordinate interactions with global regulatory authorities to ensure acceptance, rapid review and approval of applications,
supplements/variations
and submissions which present CMC information
Lead an coordinate authoring of submissions and/or sections of submissions with clients, in-house SMEs and consultants
Lead and manage of Chemistry, Manufacturing & Controls (CMC) components for products in early-to-late stage development including novels, biosimilars and cellular therapies
Develop innovative strategies and provide Regulatory Affairs input for clients and business partners on all CMC related matters
Assure Type V Master File, Letters of Authorizations, and Annual Reporting filings are maintained in accordance with regulatory requirements.
Build and scale RA capabilities through creation of a right size internal team and leveraging of consultants and partners
Qualification and Education Requirements:
BA/BS degree in molecular biology, cell biology, biochemistry, protein chemistry or similar.
Minimum of 8 years of experience in Regulatory Affairs CMC
Minimum of 10 years in related disciplines in the pharmaceutical or biotechnology industry in development, quality and cGMP manufacturing
Preferred Qualifications:
15+ years related experience with an advanced degree in related discipline
Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, process development, quality and manufacturing.
Experience collaborating with CDMOs, contractors and partners is a plus
Experience with preclinical and clinical regulatory affairs topics
RAC certification
The base pay range for this position at commencement of employment is expected to be $180,000 to $230,000; Base salary offered may vary depending on individuals skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Companys multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this Data-driven R&D Autobahn to Cures for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Companys 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to
and follow us on X/Twitter @Evotec
and LinkedIn .
Please click on the link below to access and review our Privacy Information for Applicants:
#J-18808-Ljbffr
-
Director of Process Development
1 week ago
Redmond, Washington, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
HR Director
2 weeks ago
Redmond, Washington, United States Radiant Vision Systems Full timeOverview: The Director of HR is responsible for the development and integration of talent strategies, systems and programs that support the organizations mission, vision, values and business strategy. A thought partner and collaborator with deep and broad understanding of human resources management who commands the respect of and works effectively with all...
-
Senior Flight Director, Project Kuiper
1 week ago
Redmond, Washington, United States Amazon Full timeProject Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of...
-
Senior Finance Manager, Project Kuiper
1 week ago
Redmond, Washington, United States Amazon Inc Full timeAre you ready to get in on the ground floor of Project Kuiper, Amazon's long-term initiative to design, launch, and maintain a constellation of Low Earth Orbit satellites to provide low-latency, high-speed broadband connectivity to unserved and underserved communities worldwide? It's Day 1 for Amazon's next billion-dollar business, and we are looking for an...
-
Senior Environmental Project Manager
1 week ago
Redmond, Washington, United States Atlas Full timeExternal Description Atlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in Austin, TX, Atlas currently has over 3,500 employees with offices throughout the US, including Alaska & Hawaii. It's no accident that Atlas...
-
Senior Finance Manager, Project Kuiper
1 week ago
Redmond, Washington, United States Amazon Full timeJob ID: | Services LLCAre you ready to get in on the ground floor of Project Kuiper, Amazon's long-term initiative to design, launch, and maintain a constellation of Low Earth Orbit satellites to provide low-latency, high-speed broadband connectivity to unserved and underserved communities worldwide? It's Day 1 for Amazon's next billion-dollar business, and...
-
Senior Technical Services Manager
2 weeks ago
Redmond, Washington, United States Compass Group USA Full timeEurest Salary: $125000/ year Pay Grade: 15 Other Forms of Compensation:As the leader in business and industry dining, Eurest is the company to join if you want a rewarding career packed with limitless opportunities. We feed the employees of the nation's largest and most-prestigious companies in every state and across all industries. As a member of Eurest's...
-
Senior Business Administrator
4 weeks ago
Redmond, Washington, United States Microsoft Full timeOverviewThe Teams Core Product Management group is a part of the overall Teams organization with the goal of offering best-in-class experiences to consumers. Our mission is to "Empower every person and organization to achieve more by helping them build meaningful connections with the people and communities that matter most".We are looking for an experienced...
-
Senior Business Administrator
1 month ago
Redmond, Washington, United States Microsoft Full timeOverviewThe Teams Core Product Management group is a part of the overall Teams organization with the goal of offering best-in-class experiences to consumers. Our mission is to "Empower every person and organization to achieve more by helping them build meaningful connections with the people and communities that matter most".We are looking for an experienced...
-
Incident Management Specialist
2 weeks ago
Redmond, Washington, United States WaferWire LLC Full timeJob Description: Senior Identity and Access Management (IAM)EngineerLocation: Hybrid, Redmond officePosition Overview: We are seeking a highly skilled and experienced Senior Identity and Access Management (IAM) Administrator to oversee and optimize our IAM operations. The ideal candidate will have a strong background in IAM technologies, proven leadership...
-
Senior Mechanical Engineer User Terminals
2 weeks ago
Redmond, Washington, United States SpaceX Full timeSpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal ofenabling human life on Mars.MECHANICAL ENGINEER –USER TERMINALSRESPONSIBILITIES:Define requirements and...
-
General Manager
2 weeks ago
Redmond, Washington, United States Leisure Care Full timeFairwinds RedmondWe are now seeking a General Manager / Executive Director to join our team Our hospitality-based care services and superstar employees (like you) inspire new and creative ways of doing business and serving our residents and their families. Our employees are the heart of Leisure Care communities, working to make our communities feel just like...
-
Administrative Assistant 2
1 week ago
Redmond, Washington, United States Experis Full timeJob Details:Job Title: Administrative Assistant 2Location: Redmond WA Duration: 6+ months (Possibility of Extension)Pay Rate : $30/hr-$33 /hrWe are looking for an Administrative Assistant to join one of our Fortune 500 clients.Top 3 Hard Skills Required + Years of Experience1. Minimum 3 years experience with outlook.2. Minimum 3 years experience with...
-
Executive Assistant, Devices
2 weeks ago
Redmond, Washington, United States Amazon Full timeAmazon is seeking a proactive, customer service obsessed and team-oriented Executive Assistant to support two HR Directors, and key members of the team in Amazon Devices & Services. This position will also assist in planning and facilitating internal activities and projects to support the HR team.The ideal candidate will be a detail oriented, experienced...
-
MES/Automation Engineer/Sr. Engineer
2 weeks ago
Redmond, Washington, United States Evote Full timeSenior Automation Engineer , MES– Global MSATJust Evotec Biologicsis seeking a motivated and creative Senior Automation Engineer , MESthat desires a significant opportunity to improve worldwide access to biotherapeutics . The Sr. E ngineer will be part of the Automation Team in Global MSAT that is responsible for defining the MESstandards for the J.POD...
-
Environmental, Health and Safety
4 days ago
Redmond, Washington, United States Amazon Full timeProject Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of...
-
Principal Tech Program Manager, Kuiper BizOps
1 month ago
Redmond, Washington, United States Amazon Full timeProject Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of...
-
Principal Tech Program Manager, Kuiper BizOps
2 weeks ago
Redmond, Washington, United States Amazon Full timeProject Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of...
-
Principal Tech Program Manager, Kuiper BizOps
4 weeks ago
Redmond, Washington, United States Amazon Full timeProject Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of...
-
Senior Director of Process Development
7 days ago
Redmond, United States SystImmune Inc. Full timeSenior Director of Process Development Redmond, WA Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid...
-
Senior Director of Process Development
1 week ago
Redmond, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Senior Director of Process Development
7 days ago
Redmond, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Senior Director of Process Development
1 week ago
Redmond, United States SystImmune Inc. Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Director of Process Development
1 week ago
Redmond, United States SystImmune Inc. Full timeDirector of Process Development Redmond, WA Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor...
-
Director of Process Development
1 week ago
Redmond, United States SystImmune Inc. Full timeDirector of Process Development Redmond, WA Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor...
-
Director of Process Development
1 week ago
Redmond, United States SystImmune Inc. Full timeDirector of Process Development Redmond, WA Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor...
-
Director of Process Development
1 week ago
Redmond, United States SystImmune Inc. Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Director of Process Development
2 weeks ago
Redmond, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Director of Process Development
2 weeks ago
Redmond, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Director of Process Development
7 days ago
Redmond, United States SystImmune Inc. Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Director, Drug Product Design
4 weeks ago
Redmond, United States Evotec SE Full timeDirector of Drug Product Development | Process and Product Design, Redmond WA Just-Evotec Biologics is looking for a Director of Drug Product Development to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of drug product development for the advancement of low-cost biotherapeutics manufacturing. The Director is responsible...
-
Director, Drug Product Design
2 months ago
Redmond, United States Evotec SE Full timeDirector of Drug Product Development | Process and Product Design, Redmond WA Just-Evotec Biologics is looking for a Director of Drug Product Development to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of drug product development for the advancement of low-cost biotherapeutics manufacturing. The Director is responsible...
-
Director of Process Development
1 week ago
Redmond, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Director, Drug Product Design
2 weeks ago
Redmond, Oregon, United States Evotec Group Full timeDirector of Drug Product Development | Process and Product Design, Redmond WAJust-Evotec Biologics is looking for a Director of Drug Product Development to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of drug product development for the advancement of low-cost biotherapeutics manufacturing. The Director is responsible for...
-
Director, Drug Product Design
2 months ago
Redmond, United States Evotec Full timeDirector of Drug Product Development | Process and Product Design, Redmond WAJust-Evotec Biologics is looking for a Director of Drug Product Development to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of drug product development for the advancement of low-cost biotherapeutics manufacturing. The Director is responsible for...
-
Director, Drug Product Design
4 weeks ago
Redmond, United States Evotec Full timeDirector of Drug Product Development | Process and Product Design, Redmond WAJust-Evotec Biologics is looking for a Director of Drug Product Development to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of drug product development for the advancement of low-cost biotherapeutics manufacturing. The Director is responsible for...
-
Sales and Marketing Director
2 months ago
Redmond, United States Stellar Senior Living Full timeWe call our sales team members, "Family Advisors," because that is truly their role in helping prospective residents and their families understand their options when it comes to senior living. Our Family Advisors work closely with community partners, Marketing Director, Sales, Director, Marketing, Business Services
-
Senior Director, Protein Engineering
2 months ago
Redmond, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...
-
Senior Director, Protein Engineering
2 months ago
Redmond, United States SystImmune Full timeLocated in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...