Principal/Senior Scientist Mass Spectrometry Analytics

• Full Time Position
• FULL-TIME POSITION: Principal/Senior Scientist – Mass Spectrometry Analytics
• Job Number: 9026
• FSLA Status- Exempt

Job Summary:

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

We are looking for highly qualified candidates preferably with an advanced degree (master or doctorate) in the life sciences with relevant skills and bench experience preferably in a biopharmaceutical industry setting. The selected candidate will lead all mass spectrometry and related analytical activities to support both biosimilar and innovative product development.These activities include the development and qualification of a variety of assays for characterizing and comparing product quality attributes such as:

• LC-MS/MS analyses will include methods to analyze intact and digested mAb as well as bottom-up peptide mapping approaches to include multi-attribute methods to characterize post-translational modifications such as oxidation and deamidation.
• Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method development and testing of protein drug candidates and samples with a focus on characterization of monoclonal antibody (mAb) therapeutics.
• LC-MS/MS analytical methods will also include the analysis of released glycans.
• HPLC analytical methods that either support MS analyses or parallel certain assays such as FLD detection and MS/MS detection of HILIC HPLC separation of released and labeled glycans.

Responsibilities may also include management of all outsourced high order structure (HOS) analytics to support biosimilar and innovative product development.

Experience on an Agilent 6545XT Q-TOF/1290 U-HPLC LC-MS/MS system is highly preferred.

Experience with the BYOS (Protein Metrics) mass spectrometry software platform is highly preferred.

Deep knowledge of and experience with LC-MS/MS analytical method development and qualification and experience writing analytical method SOPs and development reports are required. Experience with current Good Manufacturing Practices (cGMP) and 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 regulatory applications and/or manuscripts for publication are required.

This is an excellent opportunity to accelerate your career with an innovative, growing Biotech company and build a leadership presence in the biopharmaceutical industry. Candidates should feel comfortable working in a high risk/potential, high reward environment and be able to work flexible hours as project needs are determined. Make it happen and answer the call!

Minimum Qualifications:

• Experience with and/or knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Must have excellent communication and technical writing skills
• Must love to learn!
• Excellent level of initiative and quest for knowledge
• Must be organized and self-motivated
• Masters/Doctoral degree in life sciences preferred
• Excellent time management and proven ability to complete projects on time
• Hands on experience in mass spectrometry protein bioanalytics with monoclonal antibody-specific analyses preferred (minimum 5-7 years)

Benefits:

BioFactura offers a competitive salary with benefits such as:

·Medical, dental, vision

·Health Savings Account

·Retirement plan with company match

·STD/LTD

·Paid vacation leave

About BioFactura

BioFactura develops and commercializes biodefense drugs, novel drugs, and high-value biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal choice for bringing these products to market with faster, lower cost, superior-quality manufacture. For over 10 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.

To Apply:

Complete online application (Apply)

www.biofactura.com

BioFactura is a participant of E-verify.

BioFactura provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.