Scientist-Bacteriology

Category:

Life Science

Employment Type:

Contract

Reference:

BH-390106

Scientist-Bacteriology

Primary Duties

:
The Scientist for the Bacteriology team will design, develop, qualify, validate, and interpret functional serological assays, including serum bactericidal assays (SBA), to characterize immune responses for clinical studies across the Client's vaccine portfolio. In addition to deep immunoassay expertise, the candidate will provide mentorship and effectively collaborate with Bacteriology lab personnel to perform assigned tasks while ensuring compliance with regulatory agency standards. The candidate will serve as a key technical resource, providing expert representation within the Bacteriology group and on multidisciplinary teams. The ideal candidate will remain current on functional immunological assays specific to bacterial pathogens and embrace the evaluation of new technologies and automation to advance our testing capabilities. This is a laboratory-based role requiring a high percentage of time conducting hands-on experimental work while driving innovation in assay development.

Responsibilities Breakdown

:

80% Scientific Operations and Management

• Design, execute and troubleshoot functional immunoassays for bacterial pathogens.
• Interpret, summarize and report complex data sets with clear and concise oral and written communications.
• Serve as an internal subject matter expert on developed assays and demonstrate the ability to educate, train or mentor other team members.
• Perform/support activities to ensure test method life cycle management (documentation, method suitability/trending, maintenance, etc.).
• Support completion of analytical deliverables to meet project milestones.
• Lead and assist in the evaluation of new technologies and automation improvements to support analytical expertise as required.
• Work with internal and external partners in support of collaborative projects.

• Under direction of management, plan and oversee the day-to-day operations and general activities associated with one or more laboratories/projects.
• Ensure laboratory resources (materials/reagents/equipment/facilities) are maintained to meet assigned objectives.
• Support a quality and compliant testing environment (laboratories, equipment, reagents, training and documentation, methods, personnel).
• Maintain alignment of processes and procedures. Share best practices within team/platform.

• Oversee operational activities of staff working in the laboratory.
• Provide guidance and expert advice to staff on technical issues, safety procedures and regulatory compliance matters within the laboratory. Monitor operations to ensure compliance.
• Ensure that new employees are appropriately trained/on-boarded and familiar with laboratory operational requirements.
• Provide guidance and training for complex functional immunological assays.

• Ensure adherence to all applicable quality, corporate, safety, and regulatory requirements.
• May serve as Subject Matter Expert (SME) as required.
• Support departmental quality by ensuring adequate support for documentation, investigation, and closure of quality items including change controls, deviations, and CAPAs.

• BA/BS in scientific discipline required and/or 5-10 years equivalent industry experience or MS with 3-7 years equivalent industry experience.
• Pharmaceutical manufacturing environment with exposure to Quality and Manufacturing field is recommended.
• Broad knowledge of relevant governmental regulations, cGMP and guidelines (US, EU and other territories where Spark products are distributed), and ability to organize cGMP procedures based on regulatory / compliance regulations.

• Broad knowledge of Quality Systems such as Change Control, Investigations and CAPA.
• Ability to communicate effectively with wide range of personnel.
• Solid technical writing skills related to investigation reports.
• Ability to organize cGMP system procedures based on regulatory / compliance regulations.
• Must have strong attention to detail.
• Strong analysis and problem-solving skills, including, but not limited to, the ability to review and analyze Manufacturing, Quality Control and validation data.
• Ability to lead (as necessary) and participate on cross-functional teams in root cause analysis and solution identification.
• Proficiency with computer programs.

• To function as technical lead, establish and implement complex functional immunoassays for bacterial pathogens to use as clinical endpoint testing, as well as integration of automation technologies to increase assay throughput and reproducibility. This role operates within a regulated laboratory environment where data quality and timeline adherence are critical for vaccine development decisions. Key challenges include maintaining assay consistency while implementing automation, managing multiple concurrent projects, and adapting established protocols to different bacterial pathogens.
• Provide numerical data if available to describe the size of the job, or its impact on the business. Use annual figures and specify currency. Figures should include budgetary responsibility, purchasing authority, resources available. Highlight the key decisions made in this job. Outline the sphere of the job, such as whether the accountabilities are global, country specific, or function specific.
• Limited budgetary responsibilities. Sphere of job is function specific with some global accountability depending on project assignments.

• Physical Working Conditions
• Select the appropriate number that applies in the blank.
• Percent of Time: 1- (< 15%) 2 - (15 - 25%) 3 - (26 - 50%) 4 - (> 50%)
• Office Environment
• Lifting: Specify # lbs: 1
• Temperature Extremes: 1
• Uncomfortable Protective Clothing: 3
• Excessive Noise: 1
• Unpleasant Fumes: 1
• Dust or Dirt: 1
• Adverse Weather Conditions: 1
• Other (Specify) - N/Ap: 1
• List Hazardous Conditions: Exposure to known and unknown infectious biological agents: 3

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities