Development Scientist III, Analytical Development and Clinical Quality Control

BioCT Innovation Commons; New Haven (CT); On-site; USD 138,392 - 207,590; Full time

Benefits offered by this job

Health benefits including medical, prescription drug, dental, and vision

401(k) retirement plan

Paid vacation and holidays

Job summary

BioCT Innovation Commons is seeking a Development Scientist III in New Haven, CT, to lead the development, qualification, and optimization of bioassays essential for biotherapeutic product testing. The role includes method development and the creation of regulatory documents.

Ideal candidates will hold a Ph.D. or master's degree in a relevant field and possess at least 6 years of experience in analytical method development. A collaborative approach, strong scientific knowledge, and exceptional communication skills are required.

Qualifications

• Ph.D. with 6+ years in analytical method development.
• Experience in method qualification in biotech or pharmaceutical.
• Strong knowledge of cGMP and regulatory standards.

Responsibilities

• Develop and qualify bioassays for therapeutic proteins.
• Author SOPs and draft regulatory filing documents.
• Lead scientific problem-solving efforts across functions.

Skills

Analytical method development

ELISA binding assay

Enzymatic assay

Cell-based assay

Problem-solving skills

Interpersonal skills

MS Office proficient

Education

Ph.D. or master's degree in Biochemistry, Molecular & Cellular Biology or related

Tools

MS Office Suite

SoftMax Pro

Job description

Introduction to role:

The Development Scientist III position is a technical position responsible for development, qualification, and optimization of bioassay (biological activity/potency assay of drug candidates) and process-derived impurity methods (HCP, residual Protein A, residual DNA), in order to support release and stability testing of biotherapeutic products, and also formulation and process development. This position also supports regulatory filing (IND and BLA) and responses to Health Authorities’ queries. Participation in methods transfer, validation, troubleshooting and investigations of bioassay and impurity methods to internal and external laboratories may be required. In addition, this position is expected to interact regularly with other functional areas, such as Research, Biologic Drug Substance Development, and Injectable Drug Product Development groups as well as Manufacturing, Quality Assurance and Quality Control groups.

Accountabilities:

• Development, optimization, and phase-appropriate qualification of bioassays to evaluate quantitative biological, biochemical, and cellular activities for therapeutic proteins.

• Responsible for phase-appropriate qualification for process-derived impurity methods and impurity work strategy to support process development, product release specification, and regulatory filing.

• Makes scientific/technical proposals of strategic nature based on corporate or project objectives and understands the impact of their decisions on corporate/project objectives.

• Authors SOPs, study plans, protocols, method development/qualification reports. Drafts corresponding IND and BLA sections for regulatory filing and authors responses to health authority queries and requests.

• Leads cross-functional scientific/technical problem-solving efforts. Carries out authentic, persuasive scientific/technical presentations of strategic nature in cross-functional environment.

• Assists with prioritizing technical work efficiently to meet project timelines.

• Strong ability to multi-task and achieve milestone deliverables across multiple projects.

• Explores new innovative technologies and automation to improve throughput and efficiency of bioassay and impurity methods.

• Establish continuous improvement systems based on lessons learned and incorporate improvements into ways of doing business.

• Positively contributes to improving the working environment and engaged in on-going Alexion cultural improvement efforts.

Required Skills and Education:

• Ph.D. or master’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related discipline with a minimum of 6+ years of analytical method development and qualification experience in pharmaceutical or biotechnology setting, with high preference in ELISA binding assay, enzymatic assay, cell-based assay, and process-derived impurity methods.

• Experience with method development, optimization, qualification, validation, transfer, and investigation for biotherapeutics.

• Familiar with cGMP, ICH, USP and WHO guidelines on regulatory requirements for method qualification and validation.

• Strong scientific skills in biochemistry, molecular and cellular biology with good understanding of biological pathways and biotherapeutics’ mechanism of actions.

• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development.

• Excellent interpersonal skills and a strong ability to communicate effectively.

• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, PowerPoint, JMP and SoftMax Pro.

• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods.

• Ability to travel up to 20% to support on-site training and troubleshooting.

• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desired Skills:

• Experience in microbiology assays (e.g. bioburden, endotoxin, and sterility).

• Technical lead and/or people managing skills highly preferred.

• Has knowledge of other technical areas within ADQC/PDCS organization (Other analytical methods such as LC, CE and compendial methods within ADQC; process development and formulation development within PDCS).

The annual base pay for this position ranges from $138,392 to $207,590. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short‑term incentive bonus opportunity; eligibility to participate in our equity‑based long‑term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

02-Jun-2026

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.