Scientist, Large Molecule / Drug Substance

Source One Technical Solutions, LLC; Spring House (PA); On-site; USD 104,698,000 - 126,739,000; Full time

Job summary

Source One Technical Solutions, LLC is seeking a Scientist, Large Molecule / Drug Substance for a 3–6 month onsite contract in Spring House, PA. The candidate will join Janssen’s MSAT group to advance process development for biologics purification and perform DOE-driven experiments.

The ideal candidate has advanced degrees in chemistry/biotech with LC chromatography experience and a track record in large molecule manufacturing. Strong communication and mentoring skills are desired.

Qualifications

• Ph.D./MS/BS in Chemistry or Chemical Engineering or Biotechnology with required experience.
• Experience in liquid chromatography (Protein A, CEX, AEX) on AKTA PURE or AVANT.
• Experience with large molecule drug substance manufacturing processes.
• Knowledge of biologics solution concentration (SP-TFF and UF/DF).
• Knowledge of protein characterization methods is a plus.

Responsibilities

• Develop, design and perform process development work to support biologics purification activities.
• Design and execute experiments for upstream and downstream purification development of biologic drugs.
• Contribute to DOE and process validation activities within cross‑functional teams.
• Train and mentor other personnel; write technical memos and keep up with scientific advances.

Skills

Chromatography

Biologics purification

DOE (design of experiments)

Cross-functional teamwork

Education

PhD / MS / BS in Chemistry or Chemical Engineering or Biotechnology

Tools

AKTA PURE

AVANT system

Job description

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturing client in Spring House, PA

No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Current Temporary Authorization

Title: Scientist, Large Molecule / Drug Substance

Location: Spring House, PA

Onsite (Mon-Fri, 40 hours)

Contract Duration: 3- 6 months, with likely extension

Pay Rate: $40.00 per hour (w2)

Posting Title: - Scientist, Large Molecule / Drug Substance

The successful candidate will work in the Manufacturing Science and Technology (MSAT) department of Janssen Supply Chain (JSC-MTO) Division. The incumbent will develop, design and perform process development work to support Client biologics purification activities. The incumbent will design and execute experiments in support of upstream and downstream purification development of biologic drugs. They will propose and develop models that improve the production and purification of selected proteins. They will actively contribute to innovation efforts (e.g. new technologies) in supporting purification and analysis of proteins and large molecules. They will contribute to Designs Of Experiments (DOE). They will participate in a cross-functional team.

Process development studies will include determination and characterization of process parameters associated with liquid chromatography, concentration and filtration operations, and viral clearance.

Application of suitable reduced-laboratory scale models representative of the commercial-scale process will be a key activity in this role. The candidate will successfully support Process Analytical Technology (PAT) application including active feedback to the processing lines. These will become the basis for clinical manufacturing process instructions and Process Validation.

Experimental studies (around 90%) will include a variety of characterization studies relevant to the stage of development. The ideal candidate will be able to interpret relevant analytical data to drive biologics concentration studies, purification strategies and characterization decisions.

The successful candidate will handle samples and execute workflows and studies, collect, record, and interpret data appropriately. Data will be presented at internal meetings. The candidate will be capable of training and mentoring other personnel on techniques and equipment. They will write technical memos with minimal review and keep abreast of scientific developments in relevant fields. New concepts and technologies learned in this way will be introduced into the workflow.

Requirements

• Ph.D. / MS / BS in Chemistry or Chemical Engineering or Biotechnology or a related Scientific discipline with at least 1 / 2 / 4 years respectively of relevant experience is required
• Experience in liquid chromatography (such as Protein A, CEX, AEX) on AKTA PURE or AVANT system is required
• Experience with large molecule drug substance manufacturing process is required
• Knowledge and experience in biologics solution concentration (such as SP-TFF and UF/DF) is required

Preferred

• Knowledge and experience in protein characterization with a variety of standard analytical methods (Raman, A280, ProG, SEC, NIR, etc.) is preferred
• Experience in protein purification is preferred
• Experience in filter sizing including depth, sterile and nano filtration is preferred
• Experience in Resin Lifetime Studies is preferred
• Experience with GMP processes is preferred
• Communication skills: report writing, oral presentations
• Team player: working in cross-functional teams

What would you consider to be the top three non-negotiable skills that you would be looking for when reviewing candidate resumes?

• - experience with downstream biotherapeutic manufacturing operations (Protein A column)