Senior Scientist, CMC Analytical Development
Description

Title: Senior Scientist, CMC Analytical Development

Job Summary:  Arbor is a preclinical stage company with a growing pipeline of gene-editing programs. Our CMC Analytical Development team is looking for a Senior Scientist who will play a critical role in delivering life-changing complex biotherapeutics to patients using cutting edge technologies. This role will report to the Director of CMC Analytical Development and will drive CMC analytical activities in-house and with CDMOs to move therapeutic candidates into a cGMP environment in a phase-appropriate manner. If you are looking for an entrepreneurial, science-driven, collaborative environment then Arbor is the place for you.

Job Description

The Senior Scientist will help develop the strategy and execution of CMC analytical activities to support complex gene-editing therapeutics. The ideal candidate will thrive in a collaborative setting, working on cutting edge technology and helping transition products from R&D to GMP by championing Arbor’s CMC needs internally and externally. This role is primarily lab-based and requires proven technical expertise with relevant biochemical methodologies, including, but not limited to analytical methods for structural characterization, physicochemical properties, and product and process related impurities for gene-editing therapeutics. Experience in both upstream and downstream processing is highly desirable. The candidate will work closely with Arbor R&D and CDMOs to develop, optimize, and transfer analytical capabilities in a phase-appropriate manner. The Senior Scientist will also support the initiation and execution of early Analytical Quality Control activities including specification development, stability studies, product comparability, reference standard programs.

Key Responsibilities:

· Build and develop internal analytical capabilities, as well as relationships with external organizations (CDMOs/CRDOs) to support in-process, release, stability, and characterization testing of complex drug products.

· Author, review and approve technical documents such as test procedures, protocols & reports, investigations/deviations, and relevant regulatory submission documents (e.g., IND, IMPD, BLA, MAA).

· Work collaboratively with internal and external personnel as a hands-on analytical scientist to provide technical expertise in method development, transfer, performance, and troubleshooting, to evaluate new technologies, and to transition research methods to the GMP space. 

· Represent CMC Analytical Development on cross-functional CMC teams.

· Identify and establish critical quality attributes and implement control strategies to support Arbor’s pre-clinical toxicology and clinical development programs. Analytical activities include identification of CQAs, specification development, release and stability testing, reference standard qualification, product comparability, and structure function relationship studies.

· Serve as an analytical SME for technical input and review of investigations for aberrant results, OOT/OOS, and investigations internally and at contract organizations.

· Support Analytical/Product Development in aspects of technology transfer, process scale-up, and process validation activities at contract organizations and with partners.

  

Preferred Qualifications:

· Degree in a scientific discipline (preferably a Ph. D), with demonstrated subject matter expertise in analytical development and at least 10 years working in biopharmaceutical organizations.

· Expert knowledge of biophysical and biochemical analytical methods such as qPCR, ddPCR, ELISA, microfluidic electrophoresis (LabChip GXII), HPLC, DLS, LC-MS, GC, and Bradford and BCA assays.

· Extensive knowledge of CMC and regulatory requirements for biologics, including ICH Quality Guidelines and appropriate cGMP health authority guidelines and regulations (e.g., FDA, EMA, MHRA).

· Expert technical skills and experience with development, qualification, validation, and transfer of biophysical and biochemical analytical methods in a GLP/GxP environment to support process development, product characterization and release, and stability.

· Experience with LNP, mRNA or AAVs is highly desirable. 

· Prior experience interacting with healthcare authorities, such as scientific advisory meetings, audits, and inspections.

· Experience with setting up new lab space, including instruments and equipment qualification.

· Self-motivated, detail-oriented, strong interpersonal skills and an ability to participate and work effectively on multiple cross-functional teams. 

· You take initiative. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.

Our Values:

Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us! 

· Astonishingly Connected: The best work happens when we do it together. At Arbor, we believe strong, clear communication is crucial to our success and emboldens collaboration in all of us. 

· Our People are Gems: And we treat each other as such by celebrating our growth and development. We invest in our team and encourage everyone to have both a learner’s mindset and a willingness to teach others. 

· Remarkably Mighty: You'll be intrigued when you take a closer look at Arbor. We approach our work with integrity and thoughtfulness. We are brave, which leads us to take smart risks and make bold discoveries.

· Authenticity is Encouraged: From eating cheese puffs with chopsticks, to doing cartwheels on our balance beam, we're all about embracing your true self and showing up as you really are. Our differences make us extraordinary.

About Arbor: 

At Arbor, we are discovering, developing, and making available to all patients the next generation of genetic medicines. We are disrupting the field through our proprietary discovery engine to develop a portfolio of differentiated genetic editing and delivery capabilities. We have an unencumbered portfolio of multiple CRISPR based genetic modifiers that can be tailored to correct the underlying pathology of each genetic disease. Our pipeline of genetic medicines will focus on bringing cures to all patients with genetic disease. 

We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional.

Arbor Biotechnologies is proud to be an inclusive workplace and an Equal Opportunity Employer.