Process development associate job description

Kelly Science has a **Process Development Associate** position with a leading company in Gaithersburg MD!

You will support the development, characterization, and tech transfer of processes to manufacture purified lentiviral vectors used for pre-clinical and clinical gene therapy products.
Responsibilities:

+ Carry out all aspects of upstream vector production with the goal in mind that every effort is aimed at developing and qualifying processes required for clinical gene therapy products.

+ Order necessary supplies, maintain laboratory equipment and space, and prepare media and buffers.

Requirements:

+ B.S. Degree in the life sciences with at least 2 years of relevant experience; or equivalent combination of education and experience.

+ Previous biotech industry experience is preferred, specifically in the fields of gene therapy and virology.

+ Adherent and/or suspension mammalian cell culture, transfection and harvest of viral vectors and/or antibodies using aseptic techniques.

+ Strong experience utilizing stirred-tank bioreactors in the production of viral vectors and/or antibodies. Disposable and single use stirred-tank bioreactor experience preferred.

+ An understanding of DO/pH control loops, PID settings, and scale up and scale down parameters.

+ Practical knowledge in a range of bioprocess analytical techniques, such as but not limited to, cell-based assays, flow cytometry, qPCR, Western Blot analysis, and ELISA.

**APPLY NOW FOR IMMEDIATE CONSIDERATIN!!**

**\#P2**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** ** ** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ** **

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

• Managing and organizing data more independently - has decision-making capability and works under supervision (daily or near-daily).
• Participating as a group member and effectively communicating with all levels of the organization.
• Designing experiments after receiving general instructions for routine work and more detailed guidance for new projects. The ability to design experiments with proper controls.
• Carrying out experiments/projects using established procedures, collecting data, and running analysis alone or in collaboration with others, with recognition of unexpected results.
• Understanding scientific literature and technical documentation, implementing experimental plans to verify literature findings with direction and preparing comparison of literature to internal data for review with your manager.
• Coordinating operations of job-relevant laboratory instrumentation and data systems/management.
• Supporting technology development and improvement initiatives.
• Contributing to developing technology and automation to increase the throughput and speed of pilot scale operations.
• Building relationships within a subgroup to support shared goals and may train peers and indirectly lead, guide, and assist co-op students/interns.
• Proactively assists others in the execution of experiments and knows when to ask for help from peers.

This Role Might Be For You If:

• You enjoy a fast-paced pilot-scale laboratory setting where sound science and teamwork are the priorities.
• You contribute to lab equipment maintenance and safety to help create a safe, effective, and efficient working environment.
• You anticipate and recognize potential problems with laboratory supplies/equipment and act to prevent and tackle problems.
• You can ensure training and/or compliance responsibilities are maintained.

To be considered for this role, you must have a Bachelor's and/or Master's degree in chemical engineering, biochemical engineering, or biochemistry and 0-5+ years of experience in the biotech or pharmaceutical industry. A solid fundamental understanding of various protein purification techniques is preferred. Experience with Downstream Development and equipment including Tangential flow filters, Normal flow filters, ultrafiltration/diafiltration skids, Akta chromatography systems, disc stack centrifuge, depth filtration, chromatographic columns, HPLC, UPLC, Empower, Unicorn, JMP, LIMS, PI Historian is a plus. Experience with Raman spectroscopy and/or software programming is also a plus.

#LI-Onsite

#RDRARS

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

**HOW MIGHT YOU DEFY IMAGINATION?**

You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

**Process Development Senior Associate**

**Live**

**What you will do**

Let's do this. Let's change the world.

+ Work in a team environment to contribute to drug substance process development.

+ Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors.

+ Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed.

+ Document experimental data in lab notebooks.

+ Analyze the data and present to the team.

+ Author technical reports and support regulatory filing as needed.

+ Contribute to technology development projects to seek continuous improvement in reliability and efficiency.

The candidate will have opportunities to work in cell culture development and purification development to become a well-rounded process development scientist with experience in upstream and downstream.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

**Basic Qualifications:**

+ Bachelor's degree and 2 years of scientific or Operations experience OR

+ Master's degree

**Preferred Qualifications:**

+ Relevant hands-on lab experience in cell culture or protein purification.

+ Attention to details and critical thinking ability.

+ Experience in Design of Experiments and statistical analysis is a plus.

+ Strong oral and written communication skills.

+ Self-motivated and strong organization skills.

+ Strong interpersonal skills, and the ability to work in a dynamic and collaborative environment.

**Thrive**

**Some of the vast rewards of working here**

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

+ Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

+ A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

+ Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

**Apply now for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.