Senior Scientist
: Job Details :

Sr. Scientist in IVD Design Transfer

2-3 month contract

ESSENTIAL PRODUCT TRANSFER FUNCTIONS:

· Responsible for supporting the transfer and validation of molecular diagnostic assays, assay formulations, QC methods, and testing processes into manufacturing

· Drafts finalized transfer documents containing key manufacturing and QC processes for successful transfer of Molecular Diagnostic Assays to Operations Manufacturing and Operations QC

· Responsible for development of QC test methods and Gold Stocks for final release of raw materials, sub-assemblies, and final molecular diagnostic products

· Responsible for analyses of complex QC development data to establish QC acceptance criteria for final release of product

· Supports stability studies and quality testing plan for raw materials and/or formulations required for newly developed products, ensuring robust performance

· Supports investigations and studies of current molecular diagnostic products for continuous improvement initiatives

ESSENTIAL SENIOR SCIENTIST FUNCTIONS:

· Acts as a liaison between the company and technical partners that may be established to enhance the results of the research/development projects underway

· Conducts complex experimentation including data collection, summary, and thorough analysis, in support of department research projects and guidelines. Compose robust experimentation strategies that maximize effective use of resources and time to deliver optimal information

· Analyzes complex data sets, with understanding of relevant statistical analyses and can present findings to various audiences

· Participates as an integral member of the scientific staff in formulating research strategy and methodology

· Provides recommendations and observations to scientific staff and management on results of projects/tasks. Plays a key role in the formulation of research strategies and tactics.

· Is innovative with respect to research methods and product formulation to resolve problems and accomplish company objectives. Pro-actively recommends strategy to overcome hurdles.

· Maintains records of laboratory activities and notebooks in a professional, accurate manner. May provide support to regulatory and intellectual property activities.

· Operates complex laboratory equipment, routine maintenance, and coordinates calibration and repairs. Interfaces with contracted repair technicians as required. Understands theoretical basis for analytical instrumentation

· Operates equipment and conducts tasks in a safe manner, adhering to established guidelines and applicable regulations

· Plans, coordinates, trains, and directs the tasks of junior staff assigned to their development projects · Possesses strong technical writing skills to generate verbal and written reports as necessary and to summarize laboratory activities and projects. Initiates communication with related staff and functions as necessary to coordinate activities effectively.

· Contributes scientific leadership and innovation increasingly independent of external direction

· Assists in the professional and scientific development of junior staff members

· May represent department and/or company to outside organizations and companies, in conjunction with management

· Carries out duties in compliance with established business policies

· Performs other duties & projects as assigned

NTERACTIONS: Interact with employees in Research & Development to address scientific problems and solutions, with Manufacturing to set up and optimize prototype production, with QC staff to optimize downstream testing, and with clinical/regulatory as appropriate, and communicate conflicting project goals. Provide updates to Management and Project Teams, may participate in cross-functional teams, may lead interdepartmental project team in development of new assay or technology. Works with Manufacturing and PMO to set up and coordinate validation lots of devices and consumables. Acts as internal consultant and molecular subject matter expert.

WORK ENVIRONMENT: The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples.

PHYSICAL DEMANDS: Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted. The successful candidate will be part of a multidiscipline team involved in efforts to develop surface chemistry, bioconjugation approaches and characterize modified surfaces and biomolecules. This position will work in the lab under minimum supervision applying wet lab organic/aqueous chemistry techniques. Previous experience in working with chemicals reactive with water and /or oxygen a plus.

Primary duties include:

• Develop and execute studies including proof-of-concept, feasibility, specification, optimization, of immunoassay components and conjugation chemistries under minimum supervision.

• Apply advanced multi-disciplinary analytical techniques for the characterization of immunoassay components and conjugation chemistries in support of diagnostic assay development.

• Facilitate transfer from research to production scale as well as facilitate process transfer to manufacturing.

• Writing technical protocols, reports, and SOPs.

• Keep accurate and complete laboratory records and logs. Minimum Qualifications:

Education and Experience:

• Ph.D degree in Bioorganic Chemistry, analytical chemistry or Biochemistry required.

• Minimum of 8 years of post-graduate experience directly related in product development, and/or biotech industry.

• Experience with magnetic nanoparticles and surface chemistry highly desired.

• Deep knowledge and track record of experience in chemistry and analytical chemistry techniques, with focus on surface, or macromolecule interactions.

• Demonstrated ability to apply technical and innovative approaches to new product development. • Demonstrated experience in optimizing/troubleshooting protocols with a problem-solving mindset.

• Track record of working in a cross-functional team.

• Effective oral and written communication and presentation skills.

• Effective interpersonal skills.

• Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet project deadlines.

Requirements

EDUCATION, SKILLS & EXPERIENCE: Education and Experience

· BA/BS in life sciences, similar field or equivalent and 9-11 years of related experience, or

· MA/MS in life sciences, similar field or equivalent and at least 8 years of related experience, or

· PhD in life sciences, similar field, or equivalent and 5-8 years of related experience Product

Transfer Skills/Knowledge

· Biochemical – knowledge and hands-on experience with mathematical calculations pertaining to chemical formulations, enzyme activity assays, and a thorough understanding of current molecular biology techniques, especially qPCR.

· Experience with evaluating and transferring injection molded components and other plastics/consumables into a manufacturing environment desirable.

· Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.

· Experience with process and product validations, specification setting, and test method validations, and FDA design control documentation is preferred/a plus.

· Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.

· Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential.

· Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive, and constructive manner.

· Ability to work cross-functionally, on multiple projects, in a fast-paced environment to meet aggressive timelines, with ability to adapt as project roles and timelines require.