Principal Scientists II

Principal Scientists II

Key Roles and Responsibilities:

• Develop, conduct, and troubleshoot bioanalytical Ligand Binding Assay (LBA) methods of a wide variety with varying complexity.
• Serve as primary point of contact with clients for discovery bioanalytical projects - responsible for managing study logistics, keeping sponsors informed of study progress, and delivering quality data under strict timelines.
• Manage daily activities for a team of scientists including assigning priorities and overseeing execution of experiments to ensure timely delivery of robust bioanalytical data to clients.
• Apply advanced expertise and proficiency in implementing, configuring, and utilizing WATSON LIMS to streamline the execution of immunogenicity and pharmacokinetic assays.
• Apply expert knowledge and fluency in the deployment, setup and use of WATSON LIMS to support LBA study execution.
• Utilize comprehensive understanding of the biochemistry involved in protein labeling, specifically for the generic tagging of antibodies, fusion proteins, recombinant antibodies, and small peptides used for LBA assays.
• Provide technical training and mentoring to junior staff to foster their career growth.
• Work closely and collaboratively with the business development group to establish new clients and maintain/grow existing client relationships.
• Utilize fluency in the use, troubleshooting, and maintenance of Plate Readers (ELISA plate readers, Softmax, Bioplexand MSD) and Plate Washers.
• Independently develop innovative solutions to solve challenging study objectives.
• Evaluate and implement novel scientific approaches, technologies, or tools.
• Spearhead the creation, revision, and review of SOPs and guidelines as appropriate.
• Identify and lead operational process improvement initiatives.

Minimum Education and Qualifications:

• Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Cell and Molecular biology or related field with 5 years of experience as a Molecular or Cellular Biologist, or a closely related scientific occupation, in a non-academic setting.
• Alternatively, a Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Cell and Molecular biology or related field with 7 years of experience as a Molecular or Cellular Biologist, or a closely related scientific occupation, in a non-academic setting.
• Full competency in all aspects of bioanalysis by Ligand Binding Assay (LBA), including therapeutic pharmacokinetics, anti-drug and neutralizing antibody assays in a Contract Research Organization (CRO) environment.
• Demonstrated experience in the successful management of all phases of multiple, large, and concurrent studies employing LBA analyses, from method development and validation through sample analysis, data review and compilation as well as reporting writing in a CRO environment.
• Demonstrated experience in the effective utilization of LBA formats, such as Acid Dissociation, PandA, BEAD, branched DNA and other formats of ELISA and MSD assays across diverse immunoanalytical projects.
• Demonstrate scientific knowledge across a diverse range of large molecules, encompassing antibodies, ADCs, fusion proteins, bispecific, trispecific and endogenous biomarkers, with a track record of achieving high bioanalytical batch success and minimizing failures within stringent timelines.
• Demonstrated experience in drafting SOP/PQ/PV scripts for the deployment of Watson Software and the execution of comprehensive immunoanalytical studies for clients.
• Demonstrated successful experience such that MD/MV expectations are satisfied in routine and non-routine reagent and protein labeling as necessitated by assays.
• Experience Conducting data management tasks for clinical and non-clinical studies, which involves drafting, reviewing, and executing Data Transfer Agreements, obtaining data approvals, and generating/delivering data transfers.
• Demonstrated success, as measured by client retention, in effectively managing all aspects of effective, transparent and timely client communication and management for managed projects.
• Demonstrated success in client retention by effectively managing all aspects of the project management with active transparent and timely communication with the client.
• Demonstrated success in the development or deployment of new technologies or processes.
• Highly organized and detail-oriented in data recording and review.
• Excellent interpersonal, written, and verbal communication skills.
• Previous experience mentoring junior staff required.
• Proficiency in Microsoft Office required (Excel, Word, PowerPoint).
• Proficiency in utilizing other tools like Smartsheets, Orchards, and ZenQMS.

Work Location: Marlborough, MA

About Meadowhawk Biolabs:

Launching from our greenfield start, we seek to provide our clients with the highest quality data with fast turnround time and unrivaled client service while maintaining a focus upon technology, scientific and operational innovation.

At Meadowhawk Biolabs, our ultimate success is dependent upon building the best possible team of employees. We seek to create an environment where we celebrate our differences and value the power of diversity among our employees. We embrace cultural, social, cognitive, and professional diversity because we understand that ultimately our success is enabled by working together.