Manager, process development job description

Basic Job Functions:

Manages the Materials Engineering group. Leads process improvement projects required in the manufacturing areas of the plant. Responsible for the performance of the solar modules. Implements team building efforts in order to reach established goals and objectives.

Education and Experience:

* BS (MS or PhD preferred), majoring in chemistry, engineering, physics, material science or similar technical discipline
* 5 to 10 years working in a technical field with previous management experience in a production environment.
* Deep understanding of polymeric materials, and how to optimize them to meet product or production requirements
* Experience qualifying new materials for high volume manufacturing environment preferred
* Large scale photovoltaic or semiconductor manufacturing experience preferred
* Experience interpreting CdTe PV device electrical performance (IV, QE etc.) is a plus

Required Skills/Competencies:

* Demonstrated ability to manage and motivate others to accomplish objectives and gain desired results
* Understanding of continuous improvement/quality tools, Robust Engineering / Design of Experiments, SPC, 6 Sigma and FMEA
* Possess excellent data handling skills
* Intermediate to advanced knowledge level of computer applications, including MS Office software
* Excellent understanding of engineering techniques and practices
* Good communication skills

Essential Responsibilities

* Manage the development and continuous improvement of the robust solar module manufacturing processes in a cost-efficient manner
* Oversee the handling of module data regarding module reliability, conversion efficiency, and other key performance characteristics
* Interface with manufacturing to reduce material and labor content while meeting performance requirements
* Present project and program status reports
* Interface with other Company and customer representatives as required
* Ensure adherence to all safety and environmental procedures and housekeeping standards
* Maintain effective communication levels and fosters team building
* Assist in the development of the department and project budgets (including cost projections) and ensures adherence to the same
* Maintain department staffing levels, serve as a mentor/coach, and train and develop new and existing subordinates
* Measure staff performance and make compensation recommendations or address performance issues as necessary
* Lead engineering teams to successfully improve process performance to meet company's goal and objectives

US Physical Requirements:

* Will sit, stand, or walk short distances for up to the entire duration of a shift
* Will climb stairs on an occasional basis
* Will lift, push, or pull up to 27 pounds on an occasional basis
* Required to use hands to grasp, lift, handle, carry or feel objects on a frequent basis
* 20/40 vision in each eye, with or without correction is required
* Must be able to comply with all safety standards and procedures
* May reach above shoulder heights and below the waist on a frequent basis
* May stoop, kneel, or bend, on an occasional basis
* Ability to wear personal protective equipment is required (including but not limited to; steel toed shoes, gloves, safety glasses, hearing protection, protective jacket or apron and arm guards)
* All associates working on the production floor may be required to wear a respirator at any given time and thus, the ability to wear a respirator is a condition of employment and continued employment (requires little or no facial hair)

Potential candidates will meet the education and experience requirements provided on the above job description and excel in completing the listed responsibilities for this role. All candidates receiving an offer of employment must successfully complete a background check band any other tests that may be required.

Equal Opportunity Employer Statement: First Solar is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train, and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company.

Find what drives you on a team with a 70+ year history of being recognized for discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our portfolio is broad, so if your interests lie along the spectrum of Life Sciences to Industrial, you'll find a rewarding role here. Our career opportunities are as diverse as our products and they are all focused on creating better lives and a better planet. At Pall, we believe that innovation is our legacy, our privilege, and our destiny. If that resonates with you, join us!

Pall products have played key development and manufacturing roles in life saving medicines that range from Ebola vaccines, cancer-curing monoclonal antibodies to rare diseases. Groundbreaking research demands high quality products that combine industry-leading efficiency with high performance without sacrificing safety.

Pall Corporation of Westborough, Massachusetts is hiring for a Team Manager, Upstream Process Development. This newly created position on our Process Development Team (PDS) will provide leadership and process development expertise for the development of gene therapy and biologics related processes.

The Accelerator Process Development group at Pall specializes in designing, optimizing and transferring scalable processes from pre-clinical to validated cGMP ready manufacturing. This individual will lead or contribute to various cross functional teams ensuring a smooth technical transfer process from/to external sites on the behalf of our customers. The talent we seek has experience with stired tanks, mammalian cell culture, viral vector or biologics production operations.
Essential Job Functions/Responsibilities
Oversees the local Process Development Services operations for the upstream laboratory.
Responsible for talent management to ensure the continued development of direct reports.
The primary technical point of contact within PDS, including: SOP Generation, investigations, and resolution of complex technical issues.
Ensure well-organized, clear and complete documentations of all activities across all areas of responsibility.
Set clearly defined goals/objectives to ensure delivery of high quality results.
You are passionate scientist focused on gene therapy or biologics-related upstream processes and equipment.
Experienced in tech transfer activities: ensuring sufficient quantities, quality, and timeliness of results are maintained.
The leader of technical investigations and risk assessments related with processes.
Generate SOPs, raw material specifications, master batch records and reports for tech transfer and development processes.
Perform independent data recording, analysis and troubleshooting.
Document development work in concise reports and provide project updates in written and oral presentations
Lead and execute continuous process improvement activities aimed at providing robustness, capacity and productivity.
Maintain a high level of interaction and collaboration with the downstream and analytics teams.
Provide technical support, training and audits to internal and external collaborators.
Perform occasional extended hours and weekends to support ongoing lab activities as needed.

Qualifications/Education
Bachelor's degree in a relevant field. Master's Degree or Ph.D. in life science or Engineering preferred.

Experience:
10 years of experience in engineering, molecular biology, biochemistry, or related scientific or biopharmaceutical industry
3 years in process development or clinical manufacturing laboratory setting with a focus on upstream process development, planning and execution of projects, tech transfer and mammalian cell culture processes (thaw to production).
Bioreactor experience includes: sired-tank bioreactors, fixed bed to several hundred liters.
Experience managing technical teams and ability to lead innovation, change and drive for results.
Experience working in a Biosafety Level 2, follow safe lab procedures and maintain good laboratory practice (GLP).

Pall Corporation is proud to be part of the Danaher global family of more than 20 operating companies, driving meaningful innovation in some of today's most dynamic, growing industries. Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world-class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here .

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

The analytical development team in the Process and Analytical Development (PAD) Department is seeking an experienced and highly motivated analytical scientist and team leader in cell biology, molecular biology and/or biochemistry to lead development of biological assays for gene-edited cell therapy. The successful candidate will lead a team of scientists, coordinate with other departments, and play a key role in the development and characterization of novel cell therapy products for multiple therapeutic areas. This is an excellent opportunity to be at the cutting edge of engineered cell medicines with the powerful CRISPR-based gene editing.
Key Responsibilities

Lead a team of scientists and associates to develop and optimize fit-for-purpose biological assays for identity, gene editing, impurity, potency, etc. of ex vivo CRISPR gene-edited cell therapy products.

Develop analytical strategy and work plan for the Cell AD team, and provide guidance to direct reports.

Author and review test methods, technical reports, and supporting procedures.

Manage analytical method technical transfer from Research into AD, and from AD to internal QC and external CDMOs and CTLs.

Support QC with required data, technical support (e.g., investigations, specifications, comparability, and assay qualification/validation), and document reviews.

Support process development and related studies (formulation, stability, shipping, etc.), and characterize drug substances and drug products.

Lead assessment and implementation of new technologies and assay platforms.

Participate and present in cross-functional program teams and lead analytical sub-teams.

Support CMC-related regulatory filings for cell therapy programs by authoring and reviewing documents and providing technical expertise on analytical methods and strategies.

Requirements

Knowledge, Skills & Capabilities:

Strong background in cell biology and molecular biology.

Demonstrated ability to develop molecular and cellular assays for cell and gene therapies.

Experience and/or knowledge of CRISPR/Cas9 gene editing technologies a plus.

Broad knowledge of new technologies in the biotechnology field and a track record of innovation.

Experience in leading a team of direct reports and providing guidance and mentorship to junior scientists.

Experience in leading cross-functional collaborations with other departments (e.g., research, process development, QC) as well as external CROs/CDMOs.

Knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.

Attention to detail, strong organizational skills, and ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment.

Strong verbal and written communication, time management, record keeping and data analysis skills.

Education & Relevant Work Experience:

PhD in life sciences-related discipline with 8+ years of relevant analytical development experience, including 5+ years of industry working experience.

Physical & Travel Requirements::

• Travel to support technical transfer efforts, as required.