Pai Pharma Jobs in Usa

Description:

Deviation Investigator Level I-III is responsible for the investigation and completion of deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence. Level III Investigators are expected to work in a cGMP environment, have working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

Share knowledge to significantly enhance performance within the organization with the long term view of constructing sustainable, high performing investigation teams.

• Draws from relevant experience to aid in real-time decisions for deviation containment and investigative response.

• Ability to manage moderate to high workloads with consistent on-time delivery.

• Ability to resume in-progress investigations with limited assistance from Sr. level investigators.

• Provide direction on deviation approach for the investigators and associated investigation teams, and as this occurs, transfer knowledge to the personnel involved to elevate expertise of the teams.

• Work to achieve ?80% Right First Time on customer deviation reviews.

• Drive for effective CAPA such that deviations do not recur.

• Perform investigations for complex events with assistance from team leadership (as needed).

• Perform other duties as assigned

The Senior Manufacturing Engineer will lead modernization of legacy manufacturing processes and production documentation. The role focuses on implementing manufacturing controls derived from ISO 14971 risk management outputs and product specifications.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• Develop, update, and revise manufacturing work instructions, assembly procedures, drawings, and equipment documentation, including remediation-driven changes.
• Review DHFs and Risk Management Reports to identify CTQs requiring manufacturing controls.
• Develop and maintain PFMEAs, including process inputs, potential failure modes, and operational risks.
• Develop and implement Control Plans derived from PFMEAs, including monitoring methods and reaction plans.
• Support definition, development, and validation of manufacturing processes, assembly methods, and test methods.
• Create and execute Test Method Validation and Computer System Validation activities; improve validated inspection methods.
• Support execution of Process Validation (IQ/OQ/PQ) for manufacturing equipment and processes.
• Evaluate automated production equipment used in high?volume bottling, filling, capping, and chemical mixing processes.
• Collaborate with Quality and Validation Engineering to ensure processes maintain a validated state during routine production.
• Participate in design reviews and provide input to ensure final manufacturability of the product.
• Lead root cause analysis and recommend corrective and preventive actions for manufacturing remediation issues.
• Excellence through Integrity, Compliance, Safety and Environment
• Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
• Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
• Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
• Engage in continuous improvement initiatives, striving for operational excellence and efficiency.
• Participate in regular training and complete all training on time.

Qualifications

Education

• Bachelor’s degree or Master’s degree in Mechanical, Industrial, Manufacturing, Biomedical, or Electrical Engineering.

Experience

• 10+ years of manufacturing engineering experience in regulated manufacturing environments.
• Experience with Process Validation (IQ/OQ/PQ) and Test Method Validation (TMV).

Skills

• Strong working knowledge of risk management and process validation, including TMV.
• Comprehensive knowledge of manufacturing methods / processes, procedures and cost-reduction techniques (i.e. DFM, Lean, VAVE, Six Sigma, etc.).
• Ability to troubleshoot complex Electromechanical, Pneumatic and Software systems.
• Excellent working knowledge of medical device regulations 21 CFR, ISO 13485, ISO 14971, IVDR, and other applicable standards.
• Excellent written, verbal, and presentation abilities.
• Outstanding interpersonal skills to interact with all levels of the company, internal and external stakeholders, and oversight agencies.
• Knowledge of IPC standards (electrical) and ANSI, GDT (mechanical).
• Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
• Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
• Ability to develop and carry out corrective action plan interfacing with multiple groups when required.
• Ability to effectively communicate ideas and approaches in the form of proposals, plans and presentations.
• Ability to handle and manage multiple, complex projects and efficiently direct and coordinate the work of others.

Pay Range: $65-80/hr

Job Description:

SUMMARY: The Process Development Associate I (PDA I) provides scientific and technical support to the Process Development (PD) team. Working under direct supervision and guidance from senior PD staff, this role is responsible for executing defined laboratory tasks and established protocols to support process characterization and optimization activities. The PDA I contributes to the production of dopaminergic precursor cells (DANPCs) from induced pluripotent stem cells (iPSCs) by performing routine cell culture experiments, maintaining laboratory operations, and assisting with data collection and documentation in accordance with established procedures.

DUTIES AND RESPONSIBILITIES:

• Under supervision, perform routine laboratory experiments following established protocols to support defined unit operations and process characterization studies. • Support PD study execution by assisting designated study leads with protocol preparation, daily cell culture maintenance, sample handling, and preparation for downstream testing activities.

• Perform cell culture activities using established aseptic techniques, including media preparation and routine culture maintenance, in accordance with standard operating procedures.

• Collect experimental data and assist with data organization, review, and documentation; contribute to summaries and reports under guidance.

• Maintain accurate and timely laboratory documentation in compliance with departmental and quality requirements.

• Prepare or help verify cell culture media preparation to support ongoing experiments within the PD team.

• Support cross functional activities by coordinating with teams such as Analytical Development, Manufacturing Operations, MSAT, Device, and Research as directed.

• Assist with tracking and maintaining laboratory inventory, including media, reagents, and consumables, and support material forecasting activities as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Bioengineering, Biomedical Engineering, Molecular Biology, Neuroscience, or a related scientific discipline is required.

• Entry level experience in academic research laboratories or a relevant industry setting is preferred.

• Cell Culture & Aseptic Technique: Foundational experience with mammalian cell culture and aseptic laboratory techniques in an academic or industry setting.

• Protocol Adherence: Ability to follow established methods, procedures, and standard operating protocols with attention to detail and accuracy.

• Data Analysis & Tools: Basic proficiency with data analysis tools or commercially available software used for scientific data evaluation.

• Documentation & Organization: Strong organizational skills with the ability to maintain accurate, timely, and compliant laboratory documentation.

• Collaboration & Teamwork: Ability to work effectively in a collaborative, team-oriented environment and support cross-functional activities as directed.

• Communication Skills: Clear written and verbal communication skills, with the ability to receive direction and provide status updates to senior staff.

WORKING CONDITIONS

Office and Lab environment. While performing the duties of this Job, the employee is frequently exposed to some toxic or caustic chemicals. This is an indoor position requiring the ability to perform experiments in the laboratory and use a computer. Some Cleanroom access is required

PHYSICAL DEMANDS While performing the duties of this Job, the employee is Regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. These work environmental characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

Position Summary

Able to perform entry level inspection, repetitive tasks associated with visual inspections and basic functional testing knowledge.

Responsible for ensuring company products are in compliance with internal and external specifications by performing a variety of routine and non?routine inspections and evaluations.

Ability to perform inspection tasks use microscopes, calipers, and micrometers. Able to complete 10-15 different inspection.

Essential Duties & Responsibilities

Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements ? Perform PCI activities for NA Notifications at the US Regional Service Center as needed.

Knowledge, Skills & Qualifications

Minimum HS graduate or GED equivalent. AA or Technical Degree preferred. ? Must have basic computer skills to regularly access and document information in a computer.

Job Summary

Provides expert analytical support and data generation for daily chemistry testing activities related to raw materials, in- process and finish products. Perform all testing in a timely and accurate manner in accordance with approved GMP documents (test methods, Specifications, SOPs). Conducts investigations, drafts and executes protocols.

Essential Functions

• Inspects components, products and/or processes to ensure conformance with standards.
• Executes laboratory procedures for sample preparation.
• Independently performs materials analysis of substantial variety & complexity using ARx test methods, compendia methods, specifications.
• Ensure all analytical operations comply with cGMPs & ARx procedures and all laboratory experiments are properly documented in notebook and are in accord with regulatory requirements.
• Conducts method qualification, validation projects work from established documents using basic analytical techniques.
• Participates in the execution of validated test method transfer protocols; drafts & independently executes protocols.
• Recommends / initiates modifications of existing quality or production standards to achieve optimum quality with the equipment’s capability.
• Works independently to accomplish same and assists management in prioritization as needed.
• Conducts investigation of out-of-specification (OOS) or out-of-trend (OOT) results.
• Trains and/or mentors lower level chemists.
• Specializes and acts as lead expert in particular areas of quality control (e.g. methods, method development, statistical process control, etc.).
• Abide by the ARx Laboratory Chemical Hygiene Plan and other safety policies.Maintains a safe and clean work environment, notifying the supervisor of unsafe practices, conditions, or acts; takes on increasing responsibility for surfacing and implementing improved safety practices.
• Responsible for following all applicable waste handling procedures.

Additional Responsibilities

• Completes required paperwork / documentation accurately, neatly and in a timely manner.
• Effectively communicates with other associates, supervisors and various co-workers; relays information to the next shift (as needed); voluntarily assists other associates; communicates effectively to prevent problems from occurring.
• Interacts with and/or participates on cross-functional product development teams.
• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
• Make identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established ARx guideline consistent with all regulatory requirements. Actively complies with and endorses Department and Company objectives.
• Performs other duties and responsibilities as assigned.

Job Specifications

• Requires a Bachelors (or higher) degree in Chemistry or closely related discipline (Analytical Chemistry preferred) plus a minimum of 5 years related experience.
• Knowledgeable and proficient in application of gas chromatography (headspace, high-pressure liquid & gel permeation), UV-VIS-FTIR spectroscopy, TOC, thermal and mechanical analysis (e.g. DMA, DSC, etc.); wet chemistry techniques desired.
• Mastery knowledge and understanding of scientific principles involved in the performance of analytical test methods.
• Ability to troubleshoot and perform basic maintenance to ensure optimum performance of instrumentation.
• Evidence of continuing education such as professional certification (i.e., ASQC) or college level courses related to the position.
• Ability to efficiently utilize time (coordinate several assignments concurrently).
• Ability to read and interpret documents such as test methods and procedure manuals.
• Knowledge of requirements for maintaining proper laboratory otebook documentation.
• Must have above average computer skills and knowledge; specifically in the operational use of analytical equipment have a computer interface.
• Ability to perform basic mathematical & statistical functions; capable of designing and drafting test method transfer protocols as well as executing same and writing related reports.
• Ability to apply basic statistical process control concepts such as control charting.
• Good communication skills (verbal and written).
• Excellent interpersonal skills.
• Requires common physical characteristics and abilities, such as above average agility and dexterity; physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching or similar activities should be expected.
• Work environment involves moderate risks or discomforts requiring special safety precautions, will be required to use personal protective equipment.

Sr. Associate

Thousand Oaks, CA (Onsite)

1 Year Initial Contract

Pay: $26/hr

Job Details: To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Responsibilities include:

? Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision

? Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data

? Develops and implements new protocols with moderate review

? Engages coworkers in scientific discussions

? Communicates data and interpretation to work group

? Skilled at developing systems to ensure quality data

? Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques

? Effectively trouble-shoots equipment and experimental difficulties ? Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents

? Participates in department-wide support efforts such as safety, recruiting and committees

? May train staff and/or supervise others

? Coordinates and organizes resources needed to complete the task

? Understands when to seek input and when to make independent judgments

Day to Day Responsibilities:

Lab-based position. Responsible for sample analysis with a variety of analytical techniques (LC, CE, particle analysis, compendial methods). Responsible for supporting the timely execution of process related experiments to enable tech transfers to manufacturing sites. Candidate will be required to document study/analysis execution and interpret/present results and conclusions. Participate in team/group meetings.

Requirements:

• Degree in Biology, Biochemistry or Analytical Chemistry or related field
• Experience in a Biopharmaceutical working environment
• Experience with typical bio characterization techniques such as liquid chromatography techniques, capillary electrophoresis including troubleshooting strongly preferred.
• Good interpersonal skills, the candidate will be working in a very team-focused environment. Familiarity/experience with biologic process development.

Shift options: Hours are 2:00pm - 10:30pm, Hours are 10:00pm - 6:30am

Lab Analyst I

This position performs routine testing on all samples in the Analytical Services laboratory, providing analytical data for process control, quality control, process development, product development, and waste management. Employee will be required to work eight hours shifts, and rotating days within shift every three to four months. KC Quality Control lab is a 24 hours production site that operates on three shifts.

YOUR TASKS AND RESPONSIBILITIES

• Perform routine analytical testing as directed by protocols and work instructions.

• Work a variety of shifts (including weekends and holidays).

• Request additional work to increase team productivity.

• Prepare solutions, clean glassware, dispose of solid/liquid waste and other duties to help in the overall operations of the laboratory.

• Train others on waste management.

• Alert lab leadership of issues or discrepancies involving sample integrity, supply inventory, safety concerns, or analysis irregularities.

• Communicate troubleshooting opportunities in testing processes.

• Perform routine analytical testing as directed by protocols and work instructions.

• Work a variety of shifts (including weekends and holidays).

• Request additional work to increase team productivity.

• Conduct basic (operational) preventative maintenance according to work instructions. Identify and communicate operational issues of laboratory instruments and equipment KPIs Understand and operate Laboratory Information Management System (LIMS), Chromatography Data System (CDS) system, and other instrument specific computer systems.

• Search various databases for test methods, specifications, and standards to locate information required to complete analyses.

• Promptly and accurately record, calculate and report analytical results.

• Review analytical data and various LIMS reports.

• Communicate and discuss any issues with team members and supervisor.

• Complete data entry for metrics and KPIs Identify process improvement ideas and communicate opportunities.

• Assist in improving established procedures and implementing continuous improvement projects.

• Communicate testing results to customers as required; act with customers in mind. Notify leads when supplies/consumables are at critical levels.

• Observe good safety and housekeeping practices.

• Participate in lab/site safety programs and cross site initiatives.

• Maintain knowledgeable of RCRA hazardous waste regulations, waste determinations, waste codes, and how to immediately communicate discovery of spills and leaks

Required Qualifications:

• High school diploma + a minimum of 1-year lab experience

• Good oral and written communication skills.

• High attention to details and an ability to analyze outcomes against a standard.

• Ability to diagnose the typical instrument problems with little or no assistance and provide assistance to others.

• Ability to multitask and prioritize workload to optimize efficiency and productivity of the laboratory.

Preferred Qualifications:

• 3+ years laboratory experience

• Understands basic HPLC and GC operation.

Duties:

Document Technician: The main responsibilities are: Conduct a file review in the retention warehouse (Chicago Records). Provide a daily report about the case file reviewed. Conduct and verify the inventory of record cases by Department. Participate in follow-up meeting to review these results.

Skills:

Applies acquired knowledge and skills to complete standard tasks Readily learns and applies new information and methods to work in assigned area Maintains appropriate licenses, training and certifications Works on routine assignments that require some problem resolution Works within clearly defined standard operating procedures and/or scientific methods Adheres to all quality guidelines Works under moderate degree of supervision Work typically involves regular review of output by work lead or supervisor Refers complex unusual problems to supervisor

Education:

HS Diploma, GED or equivalent experience, preferred 1-2 years experience in related field, preferred

Biotechnician – Conjugation

Duties:

Performs efficiency studies (assays) and pre-clinical exploratory safety studies. Performs testing of clinical, research and quality control proficiency; evaluates instruments. Evaluates and analyzes clinical research data. Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. Manages storage of research samples.

Skills:

Assays

Education:

Associates

Duties:

• Accurately picks (using RF gun), packs, stages, scales, and loads customer orders for external/internal movement and prepares all pertinent documentation.
• Monitors and maintains an adequate supply of operating supplies and informs Coach when supplies need to be ordered.
• Maintains / back fills their respective areas keeping the supplies available.
• Performs clean up and light maintenance duties to maintain a high standard of housekeeping. Drives housekeeping efforts in preparation of internal and external audits
• Actively participates in and completes all company training programs for Work Instructions (WI), Standard Operating Procedures (SOP), Company Policies, and Safety programs demonstrating learned knowledge on a daily basis.
• Actively participates in all Company and Departmental meetings, Performance Centers, etc.
• Performs cycle counts on a daily basis for their assigned area using RF gun and assists in reconciling discrepancies with Inventory Control.

Skills:

Required:

• Ability to learn and apply all relevant WIs, SOPs, and other regulatory requirements.
• Ability to read information and apply what was described in the reading material to situations which may contain several details or describe processes involving several steps.
• Ability to effectively communicate both verbally and in writing to peers and management.
• Must have reliable transportation as position requires working at warehousing facilities located at multiple sites.
• Ability to use computers to perform a variety of data-entry transactions, perform RF transactions and to retrieve information (procedures; safety,
• employment, and other information using a calculator.
• Demonstrated ability to perform basic math functions using a calculator (add, subtract, multiply, divide, rounding, etc.).
• Demonstrated high level of personal motivation and initiative and be able to work independently to complete daily tasks assigned.
• Ability to adapt and be flexible with daily work assignment changes as well as a continuously-improving work environment.
• Ability and willingness to maintain accurate and factual hard-copy and electronic records.
• Demonstrated ability and willingness to work and participate effectively in a team environment.
• Operate warehouse industrial material handling equipment as required including Pallet Jacks, Pallet Transfer, Shrink Bundler, Strapping Machines, Shrink Wrapper, Pallet Scales, Conveyor, etc.
• Ability and willingness to follow directions, as assigned by management, coaches, peers, or in written instructions.
• Attention to detail, safety, quality and customer requirements.
• Preferred: Familiarity with MS Office products (specifically Word, Outlook, and Excel) and SAP or equivalent systems.

PHYSICAL DEMANDS:

• Must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 40 pounds, and occasionally lift and/or move up to 60 pounds with assistance.

Education:

• High School diploma or GED
• 2 years GMP warehouse experience