Scientist - Formulations, Solids Wilmington United States,
What differentiates us at Alcami? Our people.
Help shape the future of medicine and join us – we are a pharmaceutical contract development manufacturing organization (CDMO).
Alcami Corporation is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies. We offer a range of services from four distinct pillars: Development Services, Analytical Testing, Drug Product, and APIs. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With six locations in the U.S. and a global location in The Netherlands, the Alcami family is growing rapidly. Picture yourself at Alcami and apply today.
As the Scientist, Formulations, you will:
The Scientist will support preformulation laboratory activities for early stage Formulation development of liquids and solid drug products of new chemical entities or new dosage forms for existing drugs. Ability to efficiently organize work with little or no supervision. Will review own work and conduct peer review. Demonstrates working knowledge of scientific principles. Assists in implementation of new methods/processes to solve problems. Prepares summaries of observations, capable of verbal and written presentations to peers. Documents proficiently in laboratory notebooks. Develops solutions, lyophilized injectables, oral liquids, solids formulations of oral capsules, immediate or modified-release tablets, or topicals. Preformulation and drug characterization. Develops sterile parenterals and oral liquids, lyophilized products, liposomal delivery systems and oral solid dose including both immediate and sustained/modified release. Will assist in maintenance and calibration of the laboratory equipment and the generation of cGMP data in solid-state analyses, polymorphic studies, spectroscopy, thermal analysis, x-ray powder diffraction, x-ray single crystal analysis and chromatographic separations for Fee-for-Service and future research efforts. Writes SOPs, training modules, technical transfer documents, specifications, summary reports, and technical reports to be sent to clients or used in regulatory filings. Updates all stability tables and maintains organized product records. May participate in scientific conferences and contributes to scientific journals. Writes client communications, deviations, specifications and investigations. May provide support in corporate research and development of patent applications. May interact with clients and participate in FDA and/or client audits. Maintains a high level of professional expertise through familiarity with scientific literature. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Determines methods and procedures on new assignments. May supervise activities of junior scientists. Trains others in technical field and provides coaching and mentoring to new employees/staff. Provides basic leadership in selected formulation technologies. Exhibits advanced troubleshooting abilities with processes, methods and/or equipment.
Qualifications for success:
- Performs laboratory work related to the development of formulations for pharmaceutical dosage forms.
- Develops solutions, lyophilized injectables, oral liquids, solids formulations of oral capsules, immediate or modified release tablets, or topicals.
- Will assist in maintenance and calibration of the laboratory equipment and the generation of cGMP data in solid-state analyses, polymorphic studies, spectroscopy, thermal analysis, x-ray powder diffraction, x-ray single crystal analysis and chromatographic separations for Fee-for Service and future research efforts.
- Writes SOPs, test procedures, specifications and summary reports.
- Updates all stability tables and maintains organized product records.
- Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
- Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
- Analyzes information for technical correctness and accuracy.
- Complies with GLPs and SOPs and transcribes data and information accurately. Peer checks information and signs for GLP review. Brings aberrant information to the attention of supervisor and executes minor QA deviations per standard operating procedures.
- Participates in company sponsored training and maintains current status of certifcations.
- Provides technical training and leadership for subordinate technical positions.
- Interacts with peers and outside departments and clients.
- Demonstrates company loyalty in relations with Company personnel and clients.
- Maintains a safe, clean, and organized work environment free of safety hazards.
- Enters project hours promptly and updates project status on appropriate tracking and/or timekeeping systems.
- Suggests improvements for safety, work quality, and productivity.
- Works the hours necessary to meet scheduling commitments; is punctual with low absenteeism.
- Provides technical presentations within the company.
- Attends in-house and national scientific meetings and conducts technical presentations.
- Provides basic leadership in selected formulation technologies.
- Required BS or BA in Pharmaceutical Sciences, Chemistry or related field with a minimum of 10+ years experience, or Master degree in Pharmaceutical Sciences, Chemistry or related field with 3 - 5+ years experience, or Doctoral degree with a minimum of 0 – 1+ years experience.
- Word and Excel.
- Extensive knowledge of chemistry and scientific calculations.
- General Lab Techniques (i.e. extractions).
- Extensive understanding of GLP/GMP Policies/Regulations.
- Knowledge of early phase drug development and use of relevant physicochemical properties for solution and/or solid dose form development.
- Extensive Laboratory Skills (equipment usage, terminology, etc).
- Spectroscopy (i.e. UV, IR, AA) Titronics (i.e. KF).
- Ability to work well in a team setting and to collaborate across working groups.
- Ability to plan and schedule multiple tasks.
- Ability to work with potent compounds and controlled substances and meet timelines.
- Solid dosage formulation development and scale up or process development.
- Strong chromatographic, spectroscopy skills.
What we offer you:
- In Wilmington, an onsite Learning Center for working parents
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- A menu of voluntary benefits including short & long term disability, life, accident, critical illness and hospital indemnity insurances
- Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
- To complement your personal financial strategy, we also have 401(k) matching
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