Head Of Downstream Manufacturing Science Jobs

10+ years of related experience in the industry,

You will work closely with the engineering team to test, validate, and implement M&V protocols within the WattCarbon platform.

You will present WattCarbon’s M&V methodologies to professional audiences in webinars, at conferences, and in other forums as needed.

You will meet individually with stakeholders on an as needed basis to explain WattCarbon’s M&V methodologies.

You will advocate for open source, transparent measurement and verification of carbon emissions and energy savings.

You will track, and where appropriate, engage with policy making at the local, state, and federal level.

Able to contribute cross departmentally through upstream operation support assignments that fall outside of downstream responsibilities

Experience in maintaining detailed records and ability to assist in document revisions

Strong computer skills including MS Office (Word, Excel)

Proven ability to establish and maintain effective working relationships with team members and managers

BioWork Certification or related certification along with technical understanding of a biotech manufacturing facility is a plus

Experienced in Startup of a new facility

• Computer skills are needed, with experience using Microsoft Access, Word, Excel, PowerPoint, and Project

• Must have a thorough understanding of US FDA Quality System Requirements, ISO/EN 13485, and MDD/MDR requirements

• Must have a working knowledge of MRP systems

• Bachelor’s degree in engineering or related field or equivalent work experience required

• Review/approve product and process change control documentation and specifications.

• Review/approve manufacturing and inspection tool design, automation systems, and related system documentation.

BS or MS in Engineering (or equivalent experience)

Experienced with product DFX processes (X=mfg, test, service, repair, installation)

Experience tracking labor efficiency and effectiveness throughout the product lifecycle, from NPI to EOL, and remake.

Don’t meet all the requirements?

Leading product DFX processes (X = manufacturing, test, service, repair & installation)

Establish and adapt common processes from lab to factories and field to streamline and optimize process and product performance

Proven experience (10+ years) in manufacturing operations, preferably in the battery materials, energy storage, chemicals or related industries.

Strong knowledge of manufacturing processes and quality control practices.

Hands-on experience in implementing process improvements and lean manufacturing methodologies.

Excellent problem-solving and analytical skills with a data-driven approach.

Effective communication and collaboration skills to work with cross-functional teams.

Collaborate with cross-functional teams to develop manufacturing processes and procedures for battery material production.

Must have: AI data science experience (min 5 years).

Experience in Vision AI, OpenCV, Dlib, Yolo

Experience in optimizing neural networks, such as pruning, etc.

Comfortable with working remotely, at least partially

Bachelor’s degree in computer science or a related field; Master's Degree preferred

Demonstrated ability to achieve results while working in a cross-functional environment

Two or more years of experience in research and development in Biopharmaceutical industry or government laboratory setting is a must.

Experience with Quality by Design and demonstrated capability to develop downstream process for purification of biomolecules, specifically large size mRNA.

Experience in Design of Experiments (DoE) & high-throughput process development (e.g. plates or robocolumns in Liquid Handling systems such TECAN)

Experience and understanding of nucleic acid analytical technologies.

Hands-on development of purification processes for mRNA manufacturing and tech transfer

Development and implementation of innovative technologies for rapid downstream development

Or 4 to 8 years of experience and/or training, or equivalent combination of education and experience.

2 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, with 2 to 4 years of related experience

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

Assist CMC team with technical transfer activities.

Assist in the creation of the Bill of Materials for the upstream/downstream process.

Assist in development and creation of the upstream/downstream process.

Proven experience in data science in client relationship management, marketing, and direct marketing.

Strong predictive modeling, and statistical analysis skills; Recommendation system experience is a plus.

A successful Senior Data Scientist will likely have the following skills and experience:

Experience with machine learning and AI.

Experience with managing a team and having direct reports

Direct Marketing with email or direct-mail experience is a plus!

Product life cycle monitoring and management experience with biologic or gene therapy products is preferred.

Experience using data management systems, analysis, and reporting tools is preferred.

Excellent written and verbal communication skills with the ability to communicate effectively across a number of disciplines and experience levels.

Prior experience and / or certification in a continuous improvement methodology (e.g. Six Sigma) is preferred

Responsible for Downstream process definition, qualification, technical support for AskBio’s late stage clinical and commercial gene therapy product portfolio.

Support equipment and reagent supplier technical evaluations, risk assessments, and raw material evaluation and qualification.

Additional responsibilities not listed may be assigned as needed by management.

Plans work to meet production and schedule requirements from clients (internal and external).

Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience)

Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.

Working knowledge of cGMP and ISO guidelines

Wellness benefits (financial planning services, mental health counseling, employer paid disability)

Establish and manage team to financial, quality, and on-time delivery KPIs to understand how our manufacturing operations are impacting our business.

Strong ability to work cross-functionally in an unstructured, ambiguous environment. Startup experience preferred.

Demonstrated strategic thinking abilities and the ability to see around corners.

Own all aspects of Manufacturing, from advising engineering teams on design considerations to factory design and production execution.

Own Atlanta office manufacturing floor, headcount, and capital expenditures forecasting related for Manufacturing.

Be accountable to AS9100D guidelines.

Basic knowledge of buffer solution preparation or purification processing is preferred

Experience in single-use platform technology is preferred

Excellent written and verbal communication skills are required

Energetic, motivated and dynamic individual.

Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Education, Experience & Skills Requirements

2+ years of people management experience

5+ years of experience in the field of medical affairs

Excellent interpersonal communication and presentation skills (including networking)

Excellent teaching skills and ability to present and discuss scientific material clearly and concisely

Skilled in clinical research and an understanding of the process of pharmaceutical product development and approval

Incorporate new products into ongoing sales/medical education curriculum

2+ years of work experience required

2+ years medical device or marketing experience preferred

Excellent presentation and interpersonal communications skills

Hard-working winners. Confident, competitive and results-oriented professionals who create a track record of success

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders

5+ years of experience in people management with a track record of building high-performance teams and growing talent

Demonstrated experience collaborating with high-level stakeholders across areas such as Finance, Marketing and Sales

12+ years of data science and machine learning experience

Strong ability to manage stakeholder relationships and foster cross-functional collaboration effectively

Outstanding communication skills, coupled with a proven aptitude for influencing and persuading key decision-makers

Experience working in tech or fintech companies

Experience collaborating with wet lab scientists and managers

12+ years of R&D experience across biotech/tech and academia including leadership of mid-size data science teams

Experience applying machine learning to protein engineering

Design a vision for a first-in-class computational and machine learning platform poised to unlock the therapeutic potential of molecular mimicry

Collaborate with the broader leadership team to develop the company’s scientific strategy

Oversee the development of computational infrastructure including integrations with lab automation, NGS data pipelines, databases, ETL services, and user interfaces

Strong communication skills, experience working with C-level stakeholders and implementing strategy

8+ years of full time experience in data science and analytics

5+ years of experience in leadership

Extensive background in fintech and finance

Hands on experience deploying machine learning and statistical models into real world applications

$200,000 - $240,000 + Competitive Benefits

Hire, retain, train, lead and develop a team of scientists/ engineers and manage departmental budget, systems, processes, and team schedules

Provide leadership and direction to the manufacturing site to define the process requirements for execution of clients manufacturing processes.

Partner with clients to define requirements and understand functional/specifications process requirements.

Function as senior leader in support of supplier technical evaluations, risk assessments, and raw material evaluation and qualification.

Minimum 10 years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and/or GMP manufacturing.

Prior drug substance development and manufacturing experience, including process validation, process transfer, commercialization, and manufacturing support and troubleshooting of downstream operations.