Scientist III - Process Development, New Biologic Entities

Scientist III - Process Development, New Biologic Entities Development
Location: 100% Onsite in Lake County, IL
Length of assignment: 1 year
Hourly Pay Rate: $56-60/hr (employee medical benefits available at a cost)

The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation, processing, and analytical technologies. We create intellectual property through new formulation compositions, lean and smart manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

We are looking for a highly motivated person who supports and drives process development activities for NBEs. The candidate will maintain as well as improve our technological equipment to expend the state-of-the-art and support the development of manufacturing processes for biologics. Furthermore, the candidate will keep and increase the state of operational excellence of our lab. Working closely with analytical and formulation scientists in an integrated group the candidate will develop productive collaborations and communications with scientific and technical teams.

Section I: Major Responsibilities:
* Supporting the process development of parenteral formulations for biologics with a focus on antibody drug conjugates.
* Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
* Being the first point of contact for the operation of advanced NBE process technologies with special emphasis on process unit operation (filling, filtration, lyophilization)
* Continuous thorough maintenance (mechanical, electrical) of process and laboratory development equipment and troubleshooting of technical issues on the machines.
* Builds strong relationships to other functional units (e.g. S&T, combination products, Analytical Development) and supports / advises activities in collaboration with partners.
* Optimize laboratory operations for efficient use of time and resources.
* Document experimental data thoroughly in lab documentation systems, make concise scientific presentations of process results and author detailed scientific technical reports.
* Responsible for compliance with all applicable policies and procedures.
* Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Section II: Qualifications:
* BS, MS, or PhD in Chemistry, Pharmaceutical, biological, engineering, food science or related discipline with typically 4(BS) or 0-2 (MS, PhD) years of relevant experience or significant technical / industrial experience in the technical field.
* Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.
* Experience with biological analytical techniques (e.g., HPLC, SEC, icIEF) preferred.
* Experienced in laboratory systems (ELN) preferred.
* Experience in Microsoft Office (Excel, SharePoint, PowerPoint, and Word) required.

Corporate Competencies:
* Builds strong relationships with peers and cross functionally with partners outside of teams to enable higher performance.
* Learns fast, grasps the "essence" and can change course quickly where indicated.
* Raises the bar and is never satisfied with the status quo.
* Creates a learning environment, open to suggestions and experimentation for improvement.
* Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Other Job Details:

1) What hours and days will this person be working? 40 hours and 5 days per week
2) What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: Design and execution of studies related to biological formulation/process development
b. Required Skill 2: Familiarity with biological processing unit operations (e.g., freeze thaw, mixing, filtration, filling, and lyophilization)
c. Required Skill 3: Familiarity with biological analytical techniques (e.g., HPLC, SEC, icIEF, HIC, etc.)
d. Required Skill 4: Strong interpersonal/collaborative skills
e. Required Skill 5: Microsoft Office suite (PowerPoint, Excel)
3) What years of experience, education, and/or certification is required? BS, MS, or PhD in Chemistry, Pharmaceutical, biological, engineering, food science or related discipline with typically 4(BS) or 0-2 (MS, PhD) years of relevant experience or significant technical / industrial experience in the technical field.
4) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Experience with Electronic Lab Notebook (ELN), further analytical skills beyond SEC, HPLC, HIC, icIEF, experience in development labs
5) What is the environment that this person will be working in (i.e. group setting vs individual role)? Group
6) Is any testing required for this role? No
7) Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Expectation for fully on-site. Occasional remote days possible
8) Other notable details about the environment from the hiring manager about this role: Although it is a group role, there is significant room for ownership of individual studies and activities to support individual growth
9) What positions/background experience do you feel are successful in this role: Previous lab experience is always good, otherwise a background in biology, biochemistry, bio or chemical engineering, or physics tends to work out

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.