Job Description

Spear Bio is a young, well-funded and rapidly growing start-up company based in Woburn, Massachusetts. We are focused on bringing to market a novel ultrasensitive immunoassay platform able of work with very small sample volumes. The commercial focus of the company is on supporting life sciences, clinical, and academic research. Our platform offers best-in-class sensitivity, lab-to-lab consistency, and flexibility.
The Bioconjugation Specialist will be responsible for performing Spear Bio\xe2\x80\x99s manufacturing activities and ensuring regulatory compliance. The role will have cross-functional responsibilities reporting to the Head of Product Development but also interfacing with commercial, finance and lab facilities teams. The Bioconjugation Specialist will be expected to have demonstrated experience in conjugation chemistry and the good knowledge of GMP production for assay technologies.
TO APPLY FOR THIS POSITION, CLICK ON THIS LINK: https://spearbio.bamboohr.com/careers/27
Responsibilities:

• We are looking for a highly motivated person who loves science and wants to be part of a dynamic and fast paced team.
• The Bioconjugation Specialist will be responsible for management of manufacturing, and will be involved in developing, qualifying, and/or validating robust methods to support product release and characterization by collaborating with internal functions groups and external CDMOs.
• Synthesize bioconjugates using established chemistries.
• Contribute to the development of new bioconjugation methodologies.

• Purify bioconjugates by size exclusion chromatography, ion-exchange chromatography, affinity chromatography and hydrophobic interaction chromatography.
• Optimize protein and antibody conjugation and purification methods.
• Working knowledge of AKTA platform or equivalents.
• Characterize bioconjugates using multiple techniques such as UV/Vis, fluorescence, HPLC, MS and
• Serve as Subject Matter Expert for internal and external matters related to QA and QC.

• Analytical techniques include, but are not limited to, Real-Time PCR, immunoassays (immunoblotting and ELISAs), and gel-based assays (SDS-PAGE and CE-SDS).
• Participates in inspection readiness activities.
• Assist with equipment qualification and/or validation activities: drafting and executing IOQ protocols, drafting and reviewing reports and other documentation.
• Responsible for conducting and/or assisting with laboratory investigations: deviations, OOS/OOT, aberrant/unexpected results, and invalid results.
• Responsible for conducting and/or assisting with the identification, initiation, and closure of quality events (Deviations and CAPAs) related to analytical testing.

• Responsible for overseeing accurate, complete and timely records (test records and laboratory notebooks), in compliance with ISO 13485. FDA 21CFR 820 and 21 CFR Part 11, EU Medical Device Regulations 93/42/EEC, and EU MDR/2017 where applicable.
• Maintains familiarity with current technology related information and/or literature and conducts project related information searches and may be involved in extensive literature searches.
• Trains others in laboratory procedures and processes, and in the design, execution, and analysis of experiments. Provides feedback to supervisor on training progress.
• Performs other duties and assumes additional departmental responsibilities as required. Performs other assignments and tasks as directed.
• Demonstrates excellent written and verbal communication skills within and between departments. Maintains appropriate laboratory records, notebooks, and other formal company documentation, as required.

• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, and exercises judgment within broadly defined practices and policies to determine appropriate conclusion and follow up action.

Requirements

• B.S. or M.S. or higher in Chemistry, Biochemistry or related degree or equivalent experience.
• 2-8 years of experience in the production, purification, and characterization of conjugate molecules on research scale and medium scale is preferred.

• Experience with bioconjugates or drug delivery modalities such as targeted peptides, oligonucleotides, or antibody-drug conjugates (ADCs), including site-specific approaches.
• Hands-on experience preferably with peptide chemistry, antibody conjugation methods
• The ideal candidate for this position will have demonstrated knowledge and understanding of GMP, QA and QC functions associated with the manufacturing of immunoassay products and compliance with ISO 9001 or similar.
• Have direct experience with immunoassay method development and optimization, as well as data analysis.
• Detailed working history with lab equipment and knowledge of lab safety protocols.

General requirements

• They must be able to work independently and have a strong understanding of the theory and the biology behind the application and the products.
• Excellent documentation, organization, communication, multi-tasking and problem-solving skills.

• The successful candidate should possess strong presentational and interpersonal skills with the capability to establish collaborative working relationships within QA/QC, and with members of the Analytical Method Development, Manufacturing teams.
• The successful candidate must be prepared to work on site in Woburn MA 100%.

TO APPLY FOR THIS POSITION, CLICK ON THIS LINK: https://spearbio.bamboohr.com/careers/27
We offer a competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. This is an opportunity to enter a high-growth startup company at an early stage. We are recruiting candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of- and the effort involved in- building an industry-leading company.
Spear Bio Inc. provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.