Lead Engineer I/II (Scientist I/Sr. Scientist)-Material Characterization

Alkermes, Inc.; Wilmington (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a multidisciplinary team at a leading biopharmaceutical company in Ohio, focusing on material characterization for drug development. This role demands strong leadership in project management and technical expertise, offering opportunities for impactful contributions to pharmaceutical processes. Candidates with a Ph.D., MS, or BS in a relevant field and respective experience in characterization techniques will thrive.

Qualifications

• 0-5 years' experience for Ph.D., 3+ years for MS, and 8+ years for BS.
• Research experience with characterization techniques is essential.
• Strong analytical and written communication skills.

Responsibilities

• Lead material characterization strategy and projects.
• Troubleshoot anomalies and conduct failure analysis investigations.
• Collaborate with engineers to enhance product and process control.

Skills

Communication

Project Management

Analysis

Education

Ph.D. in Chemical Engineering or related field

MS in Chemical Engineering or related field

BS in Chemical Engineering or related field

Tools

X-ray Diffraction (XRD)

Thermal Analysis

Spectroscopic Techniques

Optical Microscopy

Scanning Electron Microscopy (SEM)

Job description

Position Summary:

This is an opportunity for a highly motivated, entrepreneurial-spirited candidate to join our multidisciplinary team of engineers and scientists to enhance material characterization of commercial biopharmaceutical sterile liquids & suspension and oral solid dosage forms. The role is in the Manufacturing Science and Technology Department at our Wilmington, Ohio facility, centrally located within an hour's commute to the Cincinnati, Columbus, and Dayton metro areas.

Role Description:

• This individual will lead our material characterization capability supporting commercial product improvement projects and investigations.
• Lead root cause and corrective action analysis; troubleshooting anomalies and failure analysis investigations are an essential function of this position.
• Contribute to identification of techniques that improve characterization of raw materials, process intermediates and products.

Key Tasks:

• Lead material characterization strategy, including project timelines, action plans, reports, presentations, and business updates for key stakeholders.
• Key projects include powder mechanical characterization, impact of raw materials on process, and impact of process on formulation.
• Key competencies include x-ray powder diffraction, thermal analysis, microscopy (optical & SEM), FT-IR spectroscopy, and powder characterization (e.g., PSD, flowability, density, compressibility).
• Evaluate, develop, and apply new characterization methodologies that enhance our product and process understanding.
• Design and perform experimental studies to support investigations and continuous improvement opportunities.
• Work collaboratively with MSAT engineers and scientists to enhance commercial product and process control.
• Support Regulatory post-approval updates.
• Write and disseminate technical data summaries and reports.

Education and Skills:

• Degree in Chemical Engineering, Pharmaceutical Sciences, Industrial and Physical Pharmacy, Material Sciences, Chemistry
• Ph.D.: Minimum 0-5 years’ experience in pharmaceutical development and manufacturing.

or

• MS: minimum 3+ years' experience in pharmaceutical development and manufacturing.
• BS: minimum 8+ years' experience in pharmaceutical development and manufacturing
• Research and/or industry experience demonstrating successful application of state-of-art characterization techniques supporting material characterization using one or more of the following: X-ray diffraction (XRD), thermal analysis (e.g., DSC, TGA, DVS), spectroscopic techniques (e.g., IR, Raman), and particle characterization (e.g., optical microscopy, SEM, particle size analysis, flowability, pycnometry).
• Good communication and project management skills for leadership of technical projects.
• Efficient in analyzing scientific data and openly discussing conclusions in non-confrontational peer reviews. Excellent analytical and written skills.
• Knowledge of PAT and cGMP pharmaceutical regulations is a plus.

Physical Requirements:

• Must be able to work in an office and a manufacturing environment.