Scientist II, AMD

Abzena Inc.•Bristol, PA

About The Position

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Scientist II will support scientific development projects and product development programs. The individual will develop and optimize analytical methods to support process development, in-process monitoring, drug substance and drug product testing, specifications, method qualification/validation protocols and reports.

Requirements

PhD degree with at least 1-3 years of relevant laboratory experience.
Experience in method development/optimization, qualification and validation of analytical methods.
Knowledge and experienced application of analytical technologies involving primarily HPLC separations, HPLC-MS, Capillary Electrophoresis, Western blots, Immunoassays (ELISA, bioassay) other analytical protein characterization methods.
Knowledge of qualification design and implementation.
Knowledge and experience in cGMP, ICH guidelines, USP, EP following STMâs.
Proven ability to work both independently and collaboratively.

Responsibilities

Develop and conduct independently and/or collaboratively all aspects of analytical methods to support process development, product pre-formulation studies, in-process monitoring, drug substance, and drug product testing.
Provide expertise in some or all of the following methods: Separation based techniques such as: HPLC-MS, Capillary Electrophoresis, UHPLC- ELSD, and cell based assays such as ELISA Immunoassays, Western blots, Protein Titer (HPLC, ELISA and SPR), SoloVPE and other analytical protein characterization methods.
Perform method development and pre-qualification, Draft test methods and protocol, design and execute phase appropriate qualification, review analytical documents such as test methods and protocols, lead method transfer to Quality Control laboratory.
Adhere to good documentation practices.
Act as an intellectual resource for his/her area of expertise by supporting assay troubleshooting and improve analytical methods as needed. Data interpretation and statistical analysis.
Act as an effective team player achieving corporate objectives through active participation in project teams and initiation and maintenance of effective interactions with clients and Abzena sites.
Participate in strategic thinking, planning and communicates scientific data and concepts effectively.
Maintain and demonstrates knowledge of the drug development process from development through commercial manufacturing including regulatory requirements and guidelines.
Operate to the highest ethical and moral standards.
Comply with Abzena's policies and procedures.
Communicate effectively with clients, supervisors, colleagues and staff.
Participate effectively as a team player in all aspects of Abzena's business.
Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
Perform other duties as assigned.