Director, Assay DevelopmentWerfen • Norcross, Georgia, USA

Director, Assay Development

Werfen • Norcross, Georgia, USA

15 days ago

Job type

Full-time

Job description

Overview

Job Summary

Responsible for the strategic planning for the assay development and product development teams to align with corporate objectives. This position will lead the discovery design development and optimization of diagnostic products and assays for our IVD product portfolio. This role will oversee teams to drive innovation in transfusion diagnostics to meet clinical needs and regulatory requirements.

Responsibilities

Key Accountabilities

Leadership & Strategy

Lead the assay and product development teams providing scientific and technical guidance.
Create a culture of design control princples focused on developing state of the art products with the highest degree of quality
Develop and execute strategic plans for assay and product development aligned with company goals.
Collaborate with executive leadership to define product development roadmaps.

Assay and Product Development

Oversee the discovery design optimization and feasibility of serological molecular immunohematology products and assays.

Ensure robustness reproducibility and scalability of assays for clinical and commercial use.

Evaluate and implement new technologies and platforms to enhance assay performance to meet clinical needs.

Project Management

Develop and execute project plans ensuring adherence to timelines budegtary constrints and regualtory requirments.

Foster a culutre of innovation within the assay development team

Regulatory & Quality Compliance

Establish and maintain robust design processes to ensure the reliability and accuracy of diagnostic assays.

Collaborate with regulatory affaris to ensure compliance with relevant industry standards and regulations.

Team Development

Mentor and develop scientific staff on design of experiements and data analysis fostering a culture of innovation and excellence.

Focus on potential patent and publication opportunities for the team

Recruit and retain top talent in assay development and related disciplines.

Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking / Key relationships

Key crossfunctional relationships with other R&D teams Manufacturing Marketing Regulatory and Quality.

Qualifications

Minimum Knowledge & Experience required for the position :

Ph.D. or Masters degree in Biochemistry Molecular Biology Immunology or related field.

Minimum of 10 years of experience in assay and product development within the IVD or life sciences industry.

Proven leadership experience managing scientific teams and complex projects.

Deep understanding of assay technologies (e.g. ELISA PCR NGS etc).

Strong knowledge of regulatory requirements for IVD products.

Excellent communication organizational and problem-solving skills.

Management has the discretion of substituting relevant work experience for a degree and / or making exceptions to the years of experience requirement.

Skills & Capabilities :

Strong verbal and written communication skills specifically related to complex biological concepts and technical documentation

Effective collaborator across departments and with cross- functional teams

Demonstrates ability to priortize and manage multple workloads efficiently

Intermediate proficiency in Microsoft Office (Word Excel) and specialized systems (TrackWise MasterControl SharePoint).

Receptive to feedback and direction; works cooperatively with managers and peers

Proven ability to work independently and as part of a team.

Organized and detail-oriented with strong problem-solving skills.

Committed to continuous improvement and operational excellence

Maintain records and files of work and revisions according to procedures and processes by following cGDP.

Travel requirements :

Minimal only as needed for meetings and conferences (5%).

Required Experience :

Director

Key Skills

Fundraising,Management Experience,Biotechnology,Clinical Development,Clinical Trials,Research & Development,Training & Development,Grant Writing,Economic Development,Leadership Experience,Public Speaking,Product Development

Employment Type : Full-Time

Experience : years

Vacancy : 1

Create a job alert for this search

Director Development • Norcross, Georgia, USA

Related jobs

Director, Sales Engineering - Advanced Technologies - People Protection

Proofpoint • Atlanta, GA, United States

Full-time

Director, Sales Engineering - Advanced Technologies - People Protection.Director, Sales Engineering - Advanced Technologies - People Protection. We are the leader in human-centric cybersecurity.Half...Show more

Last updated: 8 days ago • Promoted

Assoc Director-DataAI Engineering

AT&T • Alpharetta, Georgia, USA

Full-time

This position requires office presence of a minimum of 5 days per week and is only located in the location(s) posted.Join AT&T and reimagine the communications and technologies that connect the...Show more

Last updated: 20 days ago • Promoted

Sr. Development Director

Atlanta Staffing • Atlanta, GA, US

Full-time

Since our founding in 1924, we've cut cardiovascular disease deaths in half, but there is still so much more to do.To overcome today's biggest health challenges and accelerate this progress, we nee...Show more

Last updated: 8 days ago • Promoted

Director Of Operations

Place Services Inc. • Canton, GA, United States

Full-time

Since 2006 we have grown largely due to how we view and treat our customers.We also provide our employees a culture that allows for growth and the opportunity to learn more about construction in th...Show more

Last updated: 21 days ago • Promoted

Director, Integration & Execution, Global Brand

BentoBox • Alpharetta, GA, US

Full-time

Director, Integration & Execution, Global Brand.Calling all innovators find your future at Fiserv.We're Fiserv, a global leader in Fintech and payments, and we move money and information in a way ...Show more

Last updated: 30+ days ago • Promoted

Sr. Development Director

American Heart Association • Atlanta, Georgia, USA

Full-time

Since our founding in 1924 weve cut cardiovascular disease deaths in half but there is still so much more to do.To overcome todays biggest health challenges and accelerate this progress we need pas...Show more

Last updated: 7 days ago • Promoted

Senior Director, GxP Quality

Generate Biomedicines • Atlanta, GA, US

Full-time

Generate : Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning, biological engineering, and medicine pioneering Generative Biology to create breakthr...Show more

Last updated: 21 days ago • Promoted

Director - Strategic Business Development

Home Depot (Management) • Atlanta, GA, US

Full-time

Strategic Business Development Director.With a career at The Home Depot, you can be yourself and also be part of something bigger. The Home Depot ("THD") is redefining the future of retail.As the 4t...Show more

Last updated: 30+ days ago • Promoted

Medical Director

National Veterinary Associates • Canton, GA, US

Full-time

Canton, GA is seeking an Medical Director / Managing Veterinarian to\njoin their caring team.We provide excellent, progressive patient care and\nclient service in an exceptional facility equipped wit...Show more

Last updated: 6 days ago • Promoted

Director Business Development - Last Mile

Ryder • Atlanta, GA, US

Full-time

The Director Business Development DBD is responsible for leading the pursuit of new business and expansion / renewal business as applicable. A successful DBD will coordinate the complete sales cycle p...Show more

Last updated: 28 days ago • Promoted

Director-Cytogenetics

Fulgent Therapeutics • Alpharetta, Georgia, USA

Full-time

CSI Laboratories a Fulgent Genetics Company.Founded in 2011 our parent entity Fulgent Genetics has evolved into a premier full-service genomic testing company built around a foundational technology...Show more

Last updated: 13 days ago • Promoted

Life Sciences Business Development Director

RxVantage • Atlanta, GA, US

Full-time

Life Sciences Business Development Director.We're looking for a Life Sciences Business Development Director who is knowledgeable of selling SaaS solutions into the commercial brand level of pharma....Show more

Last updated: 14 days ago • Promoted

Senior Director, Engineering AI Acquisition Solutions

Zeta Global • Atlanta, Georgia, USA

Full-time

Zeta Global (NYSE : ZETA) is the AI-Powered Marketing Cloud that leverages advanced artificial intelligence (AI) and trillions of consumer signals to make it easier for marketers to acquire grow and...Show more

Last updated: 6 days ago • Promoted

Plant Engineering Director (Remote) DFW / Houston TX

Dairy Farmers of America • Atlanta, GA, US

Remote

Full-time

Plant Engineering Director (Remote).Dairy Farmers of America (DFA), Dairy Brands, a dairy marketing cooperative owned by more than 12,500 family farmers, is looking for a Plant Engineering Director...Show more

Last updated: 21 days ago • Promoted

Director Engineering

Honeywell International • Atlanta, GA, US

Full-time

Upskill Gen AI / UX for AI / ML Capabilities : .Develop and implement Gen AI / UX for AI / ML knowledge and capabilities across the HUE community. Promote system thinking and storytelling techniques among key...Show more

Last updated: 30+ days ago • Promoted

Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines)

J&J Family of Companies • Atlanta, GA, US

Full-time

Senior Director, Cell Therapy Discovery (Cell & Genetic Medicines).Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.Visi...Show more

Last updated: 6 days ago • Promoted

Director, Thought Leader Engagement, Breast Oncology - Atlantic

Georgia Staffing • Atlanta, GA, US

Full-time

Director, Thought Leader Engagement (Atlantic).At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and c...Show more

Last updated: 13 days ago • Promoted

Engineering Director

JLL • Atlanta, Georgia, USA

Full-time

JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services advisory and technology fo...Show more

Last updated: 23 days ago • Promoted