Are you tired of that slow climb up the career ladder? Ready to apply all that experience and make a real impact? Then this is your chance!

Our client is seeking highly motivated applicants with an entrepreneurial spirit for a leadership position in our growing enterprise.

They are looking for highly qualified candidates with an advanced degree (master or doctorate) in the life sciences with relevant skills and bench experience in a GMP industry setting.

The selected candidate will lead all bioanalytical activities including the development and qualification of a variety of bioassays for ensuring product quality such as:

• Cell-based potency assays including engineered cell lines with reporters (colorimetric, luminescent, fluorescent) as well as measuring responses such as cytokine release due to signal path activation (e.g., interferon gamma due to an inflammatory pathway activation).

• Cell-based viral neutralization assays such as Plaque Reduction Neutralization Test (PRNT).

• ELISA assays such as potency (e.g., ligand binding) and process residuals (e.g., residual host cell proteins, residual Protein A).

• SPR (Biacore) or BLI (Octet) kinetics assays for determining on and off rates as well as affinity for protein-protein interactions.

• qPCR assays such as residual host cell DNA or other qPCR-based assays.

Responsibilities also include:

• Management of all outsourced non-clinical studies such as animal efficacy and GLP toxicology.
• Management of all outsourced and in-house clinical bioassay development and qualification. This is a VERY important position of leadership and responsibility with continuous challenges along many fronts.
• Deep knowledge of and experience with analytical method qualification/validation and current Good Manufacturing Practices (cGMP) and experience writing analytical method SOPs and development reports are required.
• Experience with design of experiments (DOE) is a plus.
• Excellent communication skills and the ability to analyze and interpret data, design appropriately controlled experiments, and maintain up-to-date documentation are a must.
• Experience in the preparation and delivery of oral and written presentations, as well as participation in the preparation and submission of grant applications and/or manuscripts for publication, are required.
  

This is an excellent opportunity to accelerate your career with an innovative, small, young Biotech company and build a leadership presence in the biopharmaceutical industry. Candidates should feel comfortable working in a fast-paced, high reward environment and be able to work overtime and weekends as project needs are determined. Make it happen and answer the call!

Minimum Qualifications:

• Masters/Doctoral degree in life sciences

• Hands-on experience in protein bioanalytics (minimum 5-7 years)

• Experience with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

• Excellent time management and proven ability to complete projects on time

• Excellent level of initiative and quest for knowledge

• Must be organized and self-motivated

• Must have excellent communication and technical writing skills

• Must love to learn!

Benefits:

Our client offers a competitive salary and benefit plan including health insurance (medical, dental & prescription), health savings account and a retirement plan with employer match.