Project Manager II - R&D(H)
Posted
Summary
An on-site analytical chemistry project manager at a pharmaceutical testing lab in Oklahoma City: develops and validates methods (HPLC, LC-MS/MS, IC, ELISA) for pharma products, manages multiple cGMP research projects, and communicates results to clients.
Summary
The Project Manager II position offers an opportunity for self-direction to develop and validate analytical methods (such as HPLC, LC-MS/MS, IC, or ELISA) for pharmaceutical products and to manage the technical aspects of projects. Working independently with general oversight, Project Manager II will utilize technical expertise to provide a high level of scientific analytical support, research, and service to projects and clients. This position requires knowledge of commonly used concepts, practices, procedures, and instrumentation used in a chemistry laboratory. This position will involve using multiple computers and software to execute daily tasks, including Microsoft Office products, Laboratory Information Management Systems (LIMS), and various other web-based systems.
This incumbent will collaborate across departments to address complex technical and operational challenges, fostering a collaborative work environment. This position will participate in discussions to assess varied technical and operational issues and situations, partnering with senior personnel to develop options and solutions. May at times lead less experienced laboratory personnel in daily tasks.
Essential Functions
- Strict Adherence to Standard Laboratory Operations, Quality Management Systems (QMS), and current Good Manufacturing Practices (cGMP)
- Develop and validate analytical methods for pharmaceutical products with single-and double-active pharmaceutical ingredients.
- Authors and implements work plans and proposals for the entire scope of work in assigned projects.
- Manage several research projects and coordinate projects related to work between multiple departments and personnel.
- Communicate with clients regarding project and sample test results.
- Participates in meetings with scientific and business development personnel to discuss technical and operational issues, including routine sample and project testing/results, Standard Operating Procedures (SOPs), and client relations.
- Coach junior department personnel on how to maintain Chemical usage with adherence to department standard operating procedures, safety, industry, and federal regulations.
- Collaborate and generate unique ideas at times, leading the discussion with junior department personnel.
- Manages chemicals with the classifications of Toxic, Corrosive, Flammable, or Oxidizing.
- Use of highly technical equipment such as High-Performance Liquid Chromatography (HPLC) and Ion Exchange Chromatography (IC) Gas Chromatography (GC), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), and/or enzyme-linked immunosorbent assay (ELISA).
- Adhere to, use, and maintain Personal Protective Equipment (PPE) and Laboratory Safety Equipment and identify hazards that may arise.
- Complete all safety training, including but not limited to OSHA, Departmental SOPs, and Company Compliance.
- Adherence to all ARL Bio Pharma safety standards, policies, procedures, and protocols.
- Maintain adequate attendance as per department and company expectations.
- Performs all other duties as assigned.
The duties listed are not comprehensive but are a representation of the function this position will perform. Duties that are similar, related, or logical are also included. The omission of specific statements does not exclude them.
Key Skills, Abilities & Success Factors
- Deep Knowledge of Current Good Manufacturing Practices (cGMP) Quality Control Test: This position will require commonly used concepts, practices, procedures, and instrumentation used in a cGMP quality control laboratory.
- High Technical Capacity: This position will require expertise in High-Performance Liquid Chromatography (HPLC) and Ion Exchange Chromatography (IC) Gas Chromatography (GC), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), and/or enzyme-linked immunosorbent assay (ELISA) and other bioanalytical techniques.
- Analytical/Problem-Solving Skills: This position will need to be able to analyze and interpret data from various tests and determine why the data is not consistent with expectations.
- Time Management: This position deals with many time-sensitive tasks, which require effective management of multiple projects simultaneously and prioritizing daily tasks.
- Professional Verbal and Written Communication: This position interacts in person, by email, and by telephone with external and internal agencies and must demonstrate a professional manner reflecting the company image.
- Organization Skills: This position interacts and maintains samples from multiple clients arriving simultaneously and needs to be accurately reported and positioned.
- Collaboration Proficiency: This position will work at times independently and within a team environment.
- Digital Literacy: This position uses MS Office applications and Laboratory Information Management System (LIMS) daily and must be able to navigate digital and web-based applications.
- Detail Proficiency: This position's work at times will be repetitive, yet each time, strong attention to detail and accuracy are required.
- Intercultural sensitivity: This position will work with diverse populations of characteristics and must demonstrate recognition of the value of diverse backgrounds, experiences, and abilities.
Expected Hours of Work.
Days and Hours of Work vary by assigned group and tasks, depending on business needs. The schedule will be discussed with the supervisor to meet the company's and department's needs.
Some Flexibility is required as occasional extensions outside the normal schedule. and weekends may be necessary to meet business needs.
Travel
No travel is required for this position.
Some Flexibility is requested, as occasional local and long-distance overnight travel, as well as weekend travel, may be required to attend trade shows, training, conferences, and other business needs.
Minimum Qualifications
Education
Bachelor's degree in Chemistry or related Science Field, or equivalent Diploma.
Work Experience:
2 years of experience in High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), and bioanalytical testing.
Preferred Qualifications:
Education
Bachelor’s degree in Chemistry or equivalent Diploma.
Work experience.
4 years of experience in High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method development.
Experience in Laboratory Information Management Systems (LIMS)
Experience in the Pharmaceutical Industry
ARL Experience.
ARL prefers internal growth. Significant ARL tenure and experience that demonstrate equivalent proficiency through direct institutional knowledge and proven track record within ARL are considered primary qualifying factors in the absence of a conferred degree.
Work Environment
Supervisory Responsibility
This position has no supervisory responsibilities.
Work Environment
This job operates in a professional Laboratory environment using typical protection equipment (Eye protection, Gloves, Lab Coats, etc.)
This role routinely involves standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
Essential duties of a laboratory environment with periodic exposure to toxic and/or hazardous chemicals, solvents, and other environmental substances
Exposure to strong odors, and varying temperatures.
Exposure to the use of chemicals with the classification of Toxic, Corrosive, Flammable, or Oxidizing.
The noise level is moderate.
Primarily dominated English-speaking workplace.
Attendance at the office is required.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential functions.
Physical Requirements:
Routinely stand and walk in the performance of duties, including walking between buildings daily, and some filing is required.
This position would require the ability to lift 50 Lbs. (If an object weighs more than 50 Lbs. ARL requires this to be a two-person job or the use of carts.
Ability to sit and stand in front of a computer and/or laboratory equipment for extended periods, with intermittent twisting/bending to reach instruments or supplies surrounding equipment.
Ability to use hand strength and finger dexterity to perform grasping and fine manipulation of precise equipment.
Operation of standard office equipment.
Must be fluent in written and spoken English to receive and communicate information for standard and complex operations and emergencies clearly and accurately.
Requires visual acuity to read and write words and numbers and to see in the normal visual range including ability to distinguish colors and shapes with or without correction.
Requires hearing in the normal audio range and communicating accurately with or without correction.
Work Restrictions:
Because of the vital nature of this work, we do not allow medical marijuana cards, and we do random drug testing on all our employees.
The Company is subject to certain federal regulations and directives regarding a drug-free workplace. Because of the Company’s federal obligations and directives, as an employee of an analytical laboratory such as ARL Bio Pharma Inc., you will be subject to drug and alcohol testing, including random testing. Marijuana is one of the substances included in the drug panel screening. Possession of a medical marijuana license will not excuse you from the testing process, or the consequences of testing positive for marijuana.
General Expectations of All ARL Bio Pharma Employees:
Scientific & Technical Competence
ARL Bio Pharma delivers comprehensive, exceptional, and exceptional analytical and microbiological solutions to help our customers meet quality standards.
Scientific and technical competence is a blend of knowledge, skill, ethics, and continuous learning. The combination results in meticulous accuracy and the development of critical problem-solving ability, innovative ideas, and solutions.
Quality
ARL Bio Pharma is committed to compliance with regulatory requirements, laboratory standards of practice, and continuous improvement.
Delivering quality also encompasses adhering to established standards and processes, learning, and adapting to improve continuously, and proactively identifying and resolving potential quality issues.
Collaboration
ARL Bio Pharma is committed to engaging internal and external stakeholders to produce optimal outcomes.
By fostering open communication, joint problem-solving, and mutual support, we can build a culture where diverse individuals feel valued, appreciated, and included. This leads to increased morale, effective problem-solving, and improved organizational performance.
Integrity
ARL Bio Pharma is committed to honesty, reliability, and transparency.
Employees are expected to uphold the highest standards of ethical conduct, demonstrating honesty, fairness, and responsibility in all aspects of their work. This means communicating truthfully, reporting data, and adhering to company policies and regulations.
Customer Service
ARL Bio Pharma is committed to understanding our customers’ needs and strives to make every touch point a positive experience.
From professionalism and problem-solving to empathy and adaptability, customers expect their interactions to be swift, knowledgeable, and personalized. This builds trust, creates memorable experiences, and leaves them feeling valued.
AAP/EEO Statement
ARL Bio Pharma, Inc. provides equal employment opportunities to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law. ARL Bio Pharma, Inc. expressly prohibits any form of workplace harassment based on race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law. Improper interference with ARL Bio Pharma, Inc. employees' ability to perform their job duties may result in discipline up to and including discharge. Further, the company takes affirmative action to ensure that applicants and employees are treated without regard to any of these characteristics.